Conformis iTotal Cruciate Retaining — Class II medical device recall Z-2849-2020
Terminated recall by Conformis, Inc., reported 2020-09-02, distributed in NV. Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
| Recall number | Z-2849-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Conformis, Inc., Billerica, MA, United States |
| Recall initiated | 2020-07-20 |
| Classified | 2020-08-22 |
| Reported by FDA | 2020-09-02 |
| Terminated | 2021-06-21 |
| Distributed | NV |
| Quantity | 1 kits |
| Reason classes | labeling |
| Serial numbers | 0469247 |
| Model numbers | TCR-121-1111-010102 |
| Expiration dates | 2021-01-31 |
Product
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
Reason for recall
Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
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-2849-2020. 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.