Brand Name: Reverse Shoulder Prosthesis — Class II medical device recall Z-1460-2026
Ongoing recall by Encore Medical, LP, reported 2026-03-04, distributed nationwide. Knee and Humeral socket implants contain incorrect labeling.
| Recall number | Z-1460-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2026-01-15 |
| Classified | 2026-02-24 |
| Reported by FDA | 2026-03-04 |
| Distributed | Nationwide (US) |
| Quantity | 20 implants |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00888912144544 |
| Lot numbers | 378P1382 |
| Model numbers | 509-00-036 |
Product
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Reason for recall
Knee and Humeral socket implants contain incorrect labeling.
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-1460-2026. 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.