iTotal Identity Posterior Stabilised — Class II medical device recall Z-0899-2022
Completed recall by Conformis, Inc., reported 2022-04-20, distributed in MS. Incorrect tibial base plate implant packaged in kit
| Recall number | Z-0899-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Conformis, Inc., Billerica, MA, United States |
| Recall initiated | 2022-02-22 |
| Classified | 2022-04-08 |
| Reported by FDA | 2022-04-20 |
| Distributed | MS |
| Quantity | 1 units |
| Serial numbers | 0496242 |
| Model numbers | TPS-301-1113-020101 |
Product
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Reason for recall
Incorrect tibial base plate implant packaged in kit
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-0899-2022. 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.