Comprehensive Shoulder Stem — Class II medical device recall Z-1403-2025
Ongoing recall by ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY, reported 2025-03-26, distributed nationwide. Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during s
| Recall number | Z-1403-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY, Oranmore, N/A, Ireland |
| Recall initiated | 2025-03-03 |
| Classified | 2025-03-20 |
| Reported by FDA | 2025-03-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DO, HK, IN, JP, KR, TW |
| UPC / GTIN / UDI-DI | 00887868267550, 00887868267567, 00887868267574, 00887868267741 |
| Lot numbers | 65901697, 65909480, 65915809, 66173214, 66173215, 66173216, 66173218, 66173219, 66173220, 66173221 |
| Model numbers | 113605, 113606, 113607, 113627 |
Product
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
Reason for recall
Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.
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-1403-2025. 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.