FDAFDA · Food and drugs·Recall number Z-2528-2026
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Published July 1, 2026 · Recall initiated: May 20, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- US Nationwide distribution.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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