RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm — Class II medical device recall Z-0282-2024
Ongoing recall by Encore Medical, LP, reported 2023-11-15, distributed in CA, FL, IN, KS, LA, ME, MN, NJ…. Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not
| Recall number | Z-0282-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2023-09-25 |
| Classified | 2023-11-08 |
| Reported by FDA | 2023-11-15 |
| Distributed | CA, FL, IN, KS, LA, ME, MN, NJ, NY, OH, RI, SC, TX |
| Quantity | 20 |
| UPC / GTIN / UDI-DI | 00888912144667 |
| Lot numbers | 390P1157 |
| Model numbers | 509-01-436 |
Product
RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
Reason for recall
Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.
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-0282-2024. 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.