Off-Axis Comprehensive Shoulder System recall (Zimmer, Inc.)
Medical deviceClass IIOngoing
Summary: Zimmer, Inc. is recalling Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241. Reason: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
What is being recalled
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Why
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution.
How to tell if yours is affected
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
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2528-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 20, 2026 |
| Reported | July 1, 2026 |
| Company | Zimmer, Inc. |
| Company location | Warsaw, IN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 435 units |
More recalls from Zimmer, Inc. · all medical device recalls · recalls from May 2026