P — Class II medical device recall Z-2949-2018
Terminated recall by DePuy Orthopaedics, Inc., reported 2018-09-05. This unit may be missing the screw/collet Assembly
| Recall number | Z-2949-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-07-18 |
| Classified | 2018-08-29 |
| Reported by FDA | 2018-09-05 |
| Terminated | 2019-04-17 |
| Countries outside the US | GB |
| Quantity | 1 |
| UPC / GTIN / UDI-DI | 10603295234135 |
| Lot numbers | C2KJ24 |
| Model numbers | 960830 |
Product
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
Reason for recall
This unit may be missing the screw/collet Assembly
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-2949-2018. 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.