Recall Register

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Conformis Inc.

FDA recalling firm · 21 enforcement events · 34 product records · 2012–2025 · MA

Conformis Inc. has 21 FDA enforcement events on this register (34 product records) between 2012 and 2025: 21 device; the busiest year was 2019 with 4.

0% of its events are Class I; the most common class is Class II (21). 4 events are listed as ongoing; the recalling firm's address is in MA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
25 Mar 2025restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip SystemDeviceClass II1Ongoing
11 Mar 2024Identity Imprint PS Tibial Tray Size 4: Lot 540287DeviceClass II1Ongoing
16 Jun 2023CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EODeviceClass II1Ongoing
14 Nov 2022iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AEDeviceClass II1Ongoing
22 Feb 2022iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101DeviceClass II1Completed
21 Sep 2020iTotal 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 instrumentation.DeviceClass II1Terminated
20 Jul 2020Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)DeviceClass II1Terminated
3 Feb 2020iTotal 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 with knee joint pain and disability whose conditions cannot be solely addressed by the use of a…DeviceClass II2Terminated
25 Oct 2019iTotal 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 whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one…DeviceClass II1Terminated
22 Aug 2019iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem RightDeviceClass II2Terminated
29 Mar 2019Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)DeviceClass II2Terminated
4 Jan 2019iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102DeviceClass II1Terminated
3 Dec 2018iTotal 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 knee replacement in patients with knee joint pain and disability whose conditions cannot be solely…DeviceClass II1Terminated
16 Oct 2018iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101DeviceClass II1Terminated
24 Jul 2017Total 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 and disability whose conditions cannot be solely addressed by the use of a prosthetic device that…DeviceClass II1Terminated
31 Oct 2016ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the…DeviceClass II1Terminated
18 Oct 2016ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device.DeviceClass II1Terminated
28 Jan 2016Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111DeviceClass II1Terminated
31 Aug 2015ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M5722INT0600230 (OUS)DeviceClass II11Terminated
19 Nov 2014Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.DeviceClass II1Terminated
17 Jul 2012Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right Knee Product Usage : Usage: The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose…DeviceClass II1Terminated

By type and class

Device21
Class II21

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

12
14
16
18
20
22
24
26
Enforcement events for Conformis Inc. by year initiated.

Questions and answers

How many FDA recalls has Conformis Inc. had?

21 enforcement events (34 product records) on this register, 2012–2025: 21 device.

Are any Conformis Inc. recalls ongoing?

4 events are listed as ongoing in the current openFDA export.

What class are Conformis Inc. recalls?

21 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.