Warsaw, IN, United States
DePuy Orthopaedics, Inc. recalls
24 recalls recorded since 2018, most recently on 12 March 2024. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls24
Ongoing (FDA)4
Terminated or completed20
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 12 March 2024
- Reason
- Product incorrectly labelled.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1456-2024
- ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Ongoing Class II Medical devices
- Recall started
- 15 February 2023
- Reason
- The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1263-2023, Z-1266-2023, Z-1264-2023, Z-1265-2023, Z-1267-2023
- Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
- Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
- Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
- Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
- Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
Ongoing Class II Medical devices
- Recall started
- 29 June 2022
- Reason
- Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain
- Distribution
- Nationwide Foreign: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lithuania, Mauritius, Mexico, Morocco, Netherlands, New Zealand, Norway, P
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1419-2022
- ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525
Ongoing Class II Medical devices
- Recall started
- 18 May 2022
- Reason
- The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clarification that the +5mm offset should be taken into consideration when using a Cathcart head in a construct for hemi-hip arthroplasty procedures.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Denmark, Finland, Germany, Greece, Guam, Hong Kong, Ireland, Netherlands, New Zealand, Norway, South Africa, Spain, Sweden, Switzerland, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1375-2022
- MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 136346000, 136347000, 136348000, 136349000, 1363
Terminated Class II Medical devices
- Recall started
- 11 March 2022
- Terminated
- 18 April 2024
- Reason
- System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause a delay in treatment
- Distribution
- Worldwide distribution - US Nationwide and the countries of Israel, Australia & New Zealand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1029-2022
- VELYS Robotic-Assisted Solution Base Product No.: 451570100
Terminated Class II Medical devices
- Recall started
- 5 January 2022
- Terminated
- 22 December 2023
- Reason
- May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
- Distribution
- US Nationwide distribution in the states of TN, TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0631-2022, Z-0632-2022
- ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003
- ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001
Terminated Class II Medical devices
- Recall started
- 7 December 2021
- Terminated
- 17 May 2024
- Reason
- Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0487-2022, Z-0490-2022, Z-0486-2022, Z-0488-2022, Z-0485-2022, Z-0489-2022, Z-0483-2022, Z-0484-2022
- GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
- GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
- GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
- GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
- GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
- GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
- GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
- GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
Terminated Class II Medical devices
- Recall started
- 9 September 2021
- Terminated
- 9 August 2023
- Reason
- Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery
- Distribution
- US Nationwide distribution in the states of CA, LA, MN, MO, NC, NE, OR, PA, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0074-2022
- ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
Terminated Class II Medical devices
- Recall started
- 10 August 2021
- Terminated
- 17 May 2023
- Reason
- Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
- Distribution
- Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2398-2021, Z-2395-2021, Z-2397-2021, Z-2396-2021, Z-2400-2021, Z-2399-2021, Z-2394-2021
- TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and
- TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and
- TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively an
- TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and
- TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and
- TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and
- TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and
Terminated Class II Medical devices
- Recall started
- 1 July 2021
- Terminated
- 1 February 2023
- Reason
- Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
- Distribution
- International distribution in the countries of Canada, France.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2348-2021
- ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Terminated Class II Medical devices
- Recall started
- 7 May 2021
- Terminated
- 9 March 2023
- Reason
- Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.
- Distribution
- Domestic: CA, CT, FL, GA, IA, IN, LA, ME, MN, MO, MT, NC, NE, NY, OH, OK, OR, PA, SC, TN, WI. Foreign: Bermuda
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1845-2021
- DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR
Terminated Class II Medical devices
- Recall started
- 22 February 2021
- Terminated
- 11 October 2023
- Reason
- Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Brazil, Austria, Belgium, Denmark, Estonia, Franc
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1314-2021, Z-1316-2021, Z-1315-2021
- ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal
- The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
- The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
Terminated Class II Medical devices
- Recall started
- 8 January 2021
- Terminated
- 17 January 2024
- Reason
- The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AK, CA, FL, IN, MI, MN, MS, NC, NY, OH, PA, TX, VA and the countries of Canada, China, Germany, Puerto Rico, Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1103-2021
- Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
Terminated Class II Medical devices
- Recall started
- 15 December 2020
- Terminated
- 14 November 2023
- Reason
- Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could lead the Apex HE to thread through the shell of the cup without stopping or to protrude internally as a result of "cross-threading". If cross-threading occurs, physicians will not feel the positive stop of the Apex HE against the cup.
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0802-2021
- Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 12
Terminated Class II Medical devices
- Recall started
- 3 January 2020
- Terminated
- 12 August 2021
- Reason
- The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.
- Distribution
- Domestic distribution to IA, MA, NY, OH, and PA. Foreign distribution to Canada, China, Hungary, United Kingdom, and Singapore. ***Updated 7/9/20*** Expanded notice includes 6 new countries: Belgium, France, Germany, Maldives, New Zealand, and UAE
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1169-2020
- SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
Terminated Class II Medical devices
- Recall started
- 21 September 2018
- Terminated
- 22 April 2020
- Reason
- There is the potential for debris/material to be found behind the O-rings in the neck trials.
- Distribution
- Worldwide Distribution - US Nationwide Distributed to accounts in AL AZ CA CO FL GA HI IA IL IN KY LA MA MD ME MI MN MS NC ND NH NJ NV NY OH OR PA SC TN TX UT VA WA, and WI. International distribution worldwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1127-2019, Z-1128-2019, Z-1129-2019
- CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
- CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
- CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
Terminated Class II Medical devices
- Recall started
- 18 July 2018
- Terminated
- 17 April 2019
- Reason
- This unit may be missing the screw/collet Assembly
- Distribution
- The devices were not distributed in the United States. The devices were distributed to the following foreign countries: Great Britain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2949-2018
- P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
Terminated Class II Medical devices
- Recall started
- 21 June 2018
- Terminated
- 6 April 2020
- Reason
- Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures.
- Distribution
- Accounts in AL, CA, CO, GA< IL, LA, ME, NC, NH, NY, OR, TX, UT, and WA. Foreign distribution to Belgium, Croatia, Cyprus, Denmark, Germany, Indonesia, Korea, Sweden, and Tunisia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2521-2018
- CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
Terminated Class II Medical devices
- Recall started
- 16 April 2018
- Terminated
- 2 April 2019
- Reason
- There may be burrs on the extraction hole threads.
- Distribution
- The products were distributed to the following US states: FL, MO, and PA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1704-2018, Z-1703-2018
- ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
- ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
Terminated Class II Medical devices
- Recall started
- 21 December 2017
- Terminated
- 1 April 2020
- Reason
- The SIGMA¿ HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being recalled based on elevated revision rates observed as part of the company s post market surveillance process.
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1219-2018
- (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemente
Terminated Class II Medical devices
- Recall started
- 28 November 2017
- Terminated
- 27 March 2020
- Reason
- The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was inverted during assembly to the body, which will cause the humeral stem to sit proud and may cause surgical delays.
- Distribution
- Distribution Level: The device removal is extended to the companies US Distributors/Sales Offices and Medical Facilities that may have used, purchased, or received the affected devices. Approximately 53 units distributed to firm's international affiliates.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1012-2018
- The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LE¿O-1100-30-000 REV D.pdf.pdf, LE¿O-1100-40-000 REV D.pdf.pdf,
Terminated Class II Medical devices
- Recall started
- 31 August 2017
- Terminated
- 12 March 2020
- Reason
- The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.
- Distribution
- Nationally
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0834-2018, Z-0833-2018
- DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA componen
- DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA comp
Terminated Class II Medical devices
- Recall started
- 26 July 2017
- Terminated
- 3 April 2019
- Reason
- Potential for Intra-operative breakage of driver tips
- Distribution
- Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0849-2018, Z-0848-2018
- Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
- Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
Terminated Class II Medical devices
- Recall started
- 12 July 2017
- Terminated
- 20 May 2019
- Reason
- Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314 / Lot No. 5292130).
- Distribution
- Nationally; US Consignees for this recall are the affected are US Distributors and US Medical Facilities (Hospitals/User Facilities) that may have purchased, used, or received the affected device.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0594-2018, Z-0593-2018
- CORAIL HIGH OFFSET STEM Collarless SIZE 14
- CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.