ConforMIS iTotal Cruciate Retaining — Class II medical device recall Z-0658-2017
Terminated recall by ConforMIS, Inc., reported 2016-12-07, distributed in CO, NV. Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
| Recall number | Z-0658-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConforMIS, Inc., Bedford, MA, United States |
| Recall initiated | 2016-10-18 |
| Classified | 2016-11-25 |
| Reported by FDA | 2016-12-07 |
| Terminated | 2016-12-07 |
| Distributed | CO, NV |
| Quantity | 2 units |
| Reason classes | labeling |
| Serial numbers | 0381024, 0381042 |
| Model numbers | TCR-111-1111 |
| Expiration dates | 2017-02-28 |
Product
ConforMIS 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.
Reason for recall
Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0658-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.