Zimmer, Inc. recalls Off-Axis Comprehensive Shoulder System
- Recalling company
- Zimmer, Inc.
- Product
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- May 20, 2026
- Reported
- Jul 1, 2026
- Distribution
- US Nationwide distribution.
- Status
- Ongoing
- Quantity
- 435 units
- Lot / codes
- 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
- Company location
- Warsaw, IN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2528-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2528-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.