Billerica, MA, United States
Conformis, Inc. recalls
15 recalls recorded since 2018, most recently on 25 March 2025. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls15
Ongoing (FDA)4
Terminated or completed11
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 25 March 2025
- Reason
- The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.
- Distribution
- US Nationwide distribution in the states of CA, FL, NV, TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1569-2025
- restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
Ongoing Class II Medical devices
- Recall started
- 11 March 2024
- Reason
- Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
- Distribution
- US Nationwide distribution in the states of FL, KS and NH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1591-2024
- Identity Imprint PS Tibial Tray Size 4: Lot 540287
Ongoing Class II Medical devices
- Recall started
- 16 June 2023
- Reason
- 30mm screws were labeled as 25mm screws.
- Distribution
- US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, & VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2405-2023
- CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
Ongoing Class II Medical devices
- Recall started
- 14 November 2022
- Reason
- Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure.
- Distribution
- US Nationwide distribution in the states of AL, AZ, CO, FL, GA, KS, KY, LA, MA, MD, MS, NE, NH, NV, NY, OH, TN, WI, WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1133-2023
- iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Completed Class II Medical devices
- Recall started
- 22 February 2022
- Reason
- Incorrect tibial base plate implant packaged in kit
- Distribution
- MS
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0899-2022
- iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Terminated Class II Medical devices
- Recall started
- 21 September 2020
- Terminated
- 12 June 2023
- Reason
- Incorrect hip components were provided in kits.
- Distribution
- US Distribution in CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0475-2021
- iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use i
Terminated Class II Medical devices
- Recall started
- 20 July 2020
- Terminated
- 21 June 2021
- Reason
- Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
- Distribution
- NV
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2849-2020
- Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
Terminated Class II Medical devices
- Recall started
- 3 February 2020
- Terminated
- 2 December 2020
- Reason
- A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
- Distribution
- US Nationwide distribution in the states of LA, NY, TN.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1628-2020, Z-1627-2020
- iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with k
- iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients w
Terminated Class II Medical devices
- Recall started
- 25 October 2019
- Terminated
- 20 May 2020
- Reason
- Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
- Distribution
- US Nationwide distribution in the state of GA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0672-2020
- iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability
Terminated Class II Medical devices
- Recall started
- 22 August 2019
- Terminated
- 8 July 2020
- Reason
- Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
- Distribution
- Distributed to consignees in MD and NV.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0063-2020, Z-0064-2020
- iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
- iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
Terminated Class II Medical devices
- Recall started
- 29 March 2019
- Terminated
- 28 April 2020
- Reason
- Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1775-2019, Z-1776-2019
- Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
- Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
Terminated Class II Medical devices
- Recall started
- 4 January 2019
- Terminated
- 29 June 2020
- Reason
- The labeling of the boxes and sterile pouches did not match the contents.
- Distribution
- The products were distributed to the following US states: NH. The products were distributed to the following foreign countries: Germany
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1079-2019
- iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Terminated Class II Medical devices
- Recall started
- 3 December 2018
- Terminated
- 26 June 2020
- Reason
- The kits were prepared with incorrect patient ID labels and may contain incorrect components.
- Distribution
- Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1108-2019
- iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total k
Terminated Class II Medical devices
- Recall started
- 16 October 2018
- Terminated
- 29 June 2020
- Reason
- The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.
- Distribution
- The products were distributed to the following US states: TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0731-2019
- iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Terminated Class II Medical devices
- Recall started
- 24 July 2017
- Terminated
- 1 February 2019
- Reason
- Implant kit mislabeled
- Distribution
- US Distribution to the states of :CA and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0600-2018
- Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ Intended for use as a total knee replacement in patients with knee joint pain
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.