Attune Posterior — Class II medical device recall Z-1267-2023
Ongoing recall by DePuy Orthopaedics, Inc., reported 2023-03-29, distributed nationwide. The subject product lots are being recalled because they received a higher than specified irradiation dose. Th
| Recall number | Z-1267-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2023-02-15 |
| Classified | 2023-03-17 |
| Reported by FDA | 2023-03-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE, IN, NZ, PL |
| Quantity | 12 units |
| UPC / GTIN / UDI-DI | 10603295049944 |
| Lot numbers | JN6613 |
| Model numbers | 151640507 |
Product
Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
Reason for recall
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
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-1267-2023. 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.