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FDAClass II · Medical device · Recalled July 1, 2026
Off-Axis Comprehensive Shoulder System Small recall — Zimmer, Inc.
Hazard: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2527-2026
- Brand
- Zimmer
- Classification
- Class II
- Units affected
- 474 units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
Affected products
Companies & origin
- Recalling firm location
- Warsaw, IN, United States
- Firm address
- 1800 W Center St, N/A, 46580-2304
Identifying details (verbatim from the notice)
- Product codes / lots
- Lot Code: Model No. 110040240 ; UDI-DI (01)00889024681965(17)350601(10)099457 ; Lot Number 099457 Model No. 110040240 ; UDI-DI (01)00889024681965(17)350712(10)099458 ; Lot Number 099458
- Distribution
- US Nationwide distribution.
- Firm notified the public via
- N/A
- FDA event ID
- 99045
- Recall initiated
- May 20, 2026
- FDA classified
- June 23, 2026
- FDA report date
- July 1, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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