REVERSE PROSTHESIS SHOULDER SYSTEM — Class II medical device recall Z-0098-2024
Ongoing recall by Encore Medical, LP, reported 2023-10-18, distributed in AZ, FL, IA, IN, KY, MN, NY, OH…. Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws.
| Recall number | Z-0098-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2023-08-22 |
| Classified | 2023-10-12 |
| Reported by FDA | 2023-10-18 |
| Distributed | AZ, FL, IA, IN, KY, MN, NY, OH, RI, SC, TX, VA, WA, WI |
| Quantity | 70 |
| UPC / GTIN / UDI-DI | 00888912024570 |
| Lot numbers | 835C2074 |
| Model numbers | 506-03-130 |
| Expiration dates | 2029-03-09 |
Product
REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
Reason for recall
Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.
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-0098-2024. 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.