⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a
very recent recall may be missing. Everything shown is accurate as of the last checked time on this page —
for anything time-critical, confirm with the official sources linked below.
FDAClass II · Medical device · Recalled July 1, 2026
Off-Axis Comprehensive Shoulder System 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-2528-2026
- Brand
- Zimmer
- Classification
- Class II
- Units affected
- 435 units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
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. 110040241 ; UDI-DI (01)00889024681941(17)350602(10)099463 ; Lot Number 099463 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350531(10)099464 ; Lot Number 099464 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350812(10)099465 ; Lot Number 099465 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350707(10)099467 ; Lot Number 099467
- 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.
Report a data error on this page