Conformis Inc. recalls
Every recall we track for Conformis Inc. — 18 in all, from 2017–2025 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Conformis Inc. peaked in 2019 (6); 18 since 2017.
All FDA recall records for Conformis Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 1 | 1 |
| 2018 | 0 | 0 | 1 | 1 | 2 |
| 2019 | 0 | 1 | 3 | 2 | 6 |
| 2020 | 0 | 0 | 3 | 1 | 4 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 1 | 0 | 1 | 2 |
| 2023 | 0 | 0 | 1 | 0 | 1 |
| 2024 | 0 | 0 | 1 | 0 | 1 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Conformis Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Conformis Inc. recalls
15 shown- Lower riskMedical device
Conformis Inc. recalls restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for
Conformis recalls specific acetabular liner models for hip systems due to incorrect labeling. This may lead to improper use. Affected customers should contact Conformis for details.
ConformisMar 25, 2025 - Lower riskMedical device
Conformis, Inc. recalls Identity Imprint PS Tibial Tray Size 4: Lot 540287
Conformis recalls Identity Imprint PS Tibial Tray Size : Lot 540287 due to packaging mix-up between lots 540287 and 508287. This may lead to incorrect product use.
ConformisMar 11, 2024 - Lower riskMedical device
Conformis, Inc. recalls CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
Conform: Hip screws labeled 25mm but actually 30mm may cause improper fit. Affected units: Model HAA-030-0625-000101, Lot 1232071. Contact manufacturer for details.
ConformisJun 16, 2023 - Use cautionMedical device
Conformis, Inc. recalls iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
Conformis recalls iTotal Identity Impactor Handle Model 1080-212/ED-07827 REV AE due to risk of screw falling into patient during procedures. Affected units have specific model and lot numbers.
ConformisNov 14, 2022 - UnratedMedical device
Conformis, Inc. recalls iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Conformis recalls iTotal Identity Posterior Stabilised Knee Replacement System model TPS-301-1113-020101 due to incorrect tibial base plate implant packaging. Affected units have specific serial numbers and UDI codes.
ConformisFeb 22, 2022 - UnratedMedical device
Conformis, Inc. recalls iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip
Conformis recalls iTotal Hip Replacement System model HAA-050-D02: Incorrect hip components in kits may lead to improper joint replacement. Affected units have serial numbers 0469255.
ConformisSep 21, 2020 - Lower riskMedical device
Conformis, Inc. recalls Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL
Conformis recalls iTotal CR knee implants with incorrect box contents. Check serial number 0469247 (exp 2021-01-31) for affected units. No immediate action needed.
ConformisJul 20, 2020 - Lower riskMedical device
Conformis, Inc. recalls iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The
Conformis recalls a limited number of iTotal PS knee replacement systems with incorrect serial numbers delivered to the wrong customers. This does not pose a safety risk but requires correction of labeling.
ConformisFeb 3, 2020 - UnratedMedical device
Conformis, Inc. recalls iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement
Conformis recalls iTotal CR Knee Replacement System model TCR-111-1111-010102 due to medial and lateral polyethylene inserts not securely fitting into the cobalt chrome tray implant.
ConformisOct 25, 2019 - Lower riskMedical device
Conformis, Inc. recalls iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
Conformis recalls hip replacement stems Model HBS-033-0015-020101 Size 15 due to switched packaging. Patients may receive incorrect stem size.
ConformisAug 22, 2019 - Use cautionMedical device
Conformis, Inc. recalls Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
Conformis recalls specific hip replacement stems due to 3mm discrepancy between iViews measurements and actual implant neck/head lengths, potentially causing improper fit.
ConformisMar 29, 2019 - Lower riskMedical device
Conformis, Inc. recalls iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Conformis recalls iTotal Posterior Stabilized knee replacement systems with mismatched labeling on boxes and pouches. Affected units include specific catalog and serial numbers. Consumers should contact Conformis for details.
ConformisJan 4, 2019 - Lower riskMedical device
Conformis, Inc. recalls iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010
Conformis recalls iTotal CR Total Knee Replacement Systems with incorrect patient ID labels and components. This could lead to wrong patient matches during surgery. Affected units have specific model numbers and serial numbers.
ConformisDec 3, 2018 - UnratedMedical device
Conformis, Inc. recalls iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Conformis recalls hip replacement system with stage 1/2 reamer instruments that may cause bone damage due to improper fit. Affected units have specific catalog and serial numbers.
ConformisOct 16, 2018 - UnratedMedical device
ConforMIS, Inc. recalls Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and
ConforMIS recalls total knee replacement kits with model TPS-111-1111 that have mislabeled implant kits. Affected units include specific serial numbers and expiration dates. Consumers should contact the manufacturer for details.
ConforMISJul 24, 2017
Conformis Inc. recall questions
How many recalls has Conformis Inc. had?
18 recalls from Conformis Inc. are on record with U.S. safety agencies, from 2017–2025.
What is the most recent Conformis Inc. recall?
Conformis Inc. recalls restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for, dated Mar 25, 2025. Every Conformis Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Conformis Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Conformis Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.