Norwood, MA, United States
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls
6 recalls recorded since 2018, most recently on 24 February 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)2
Terminated or completed4
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 24 February 2025
- Reason
- Device is missing the pin in the graft loader component.
- Distribution
- Domestic: Nationwide Distribution; Foreign: Austria, Belgium, Brazil, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Spain, Finland, France, French Guyana, Greece, Israel, India, Italy, Japan, South Korea, Luxemburg, Mexico, Netherlands, Poland, Portugal & Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1314-2025, Z-1315-2025
- COR Disposable Kit, 8 mm. Cartilage Transplant System.
- COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.
Ongoing Class II Medical devices
- Recall started
- 13 April 2023
- Reason
- IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS¿ Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Switzerland, China, Czech Republic, Germany, Egypt, Spain, United Kingdom, Hong Kong, Hungary, Ireland, India, Italy, Korea, Netherlands, New Zealand, Slovakia, Thailand.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1678-2023, Z-1679-2023, Z-1680-2023, Z-1677-2023, Z-1681-2023
- DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
- DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
- DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
- DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
- DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
Terminated Class II Medical devices
- Recall started
- 4 November 2019
- Terminated
- 5 May 2020
- Reason
- Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE¿ Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation.
- Distribution
- US: AL AZ CA CT FL IA IL IN LA MA MD ME MI MN MT NC NE NH NJ NM OH OK OR PA TN TX VA WA WI International: Belgium, Chile, China, Czech Republic, France, India, Japan, Korea, Latvia, New Zealand, Slovakia Sweden
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0665-2020, Z-0666-2020
- Healix Knotless ADV BR 4.75 Suture Anchor
- Healix Knotless ADV BR 5.5 Suture Anchor
Terminated Class II Medical devices
- Recall started
- 30 August 2018
- Terminated
- 5 June 2020
- Reason
- The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole.
- Distribution
- US nationwide in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MI, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI. The products were distributed to the following foreign countries: Australia, Canada, Chile, China, Chechnya, Denmark, Italy, Jap
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0208-2019
- Mitek Screw and Washer Depth Gauge, Product Code 219024
Terminated Class II Medical devices
- Recall started
- 22 December 2017
- Terminated
- 16 July 2019
- Reason
- Reports of product loosening or coming unscrewed from the handle.
- Distribution
- US Nationwide Distribution in the states of OH, WA, CO
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1749-2018
- LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the orthopedic surgeon with a means of bone fixation and to assist in the management
Terminated Class II Medical devices
- Recall started
- 31 August 2017
- Terminated
- 9 April 2019
- Reason
- Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0695-2018
- 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.
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.