Off-Axis Comprehensive Shoulder System — Class II medical device recall Z-2529-2026
Ongoing recall by Zimmer, Inc., reported 2026-07-01, distributed nationwide. Five complaints have been received identifying issues where the plastic guides were catching during reaming, l
| Recall number | Z-2529-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2026-05-20 |
| Classified | 2026-06-23 |
| Reported by FDA | 2026-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 429 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00889024681989 |
| Lot numbers | 099471, 099473, 099474, 099475 |
| Model numbers | 110040242 |
Product
Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
Reason for recall
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
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-2529-2026. 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.