Zimmer, Inc.: Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Zimmer, Inc.
- Product
- Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
- Reason / hazard
- Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2026-05-20
- Code info
- Lot Code: Model No. 110040476 ; UDI-DI (01)00889024682047(17)350531(10)097492 ; Lot Number 097492
- Product quantity
- 13 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Warsaw
- State
- IN
- Country
- United States
- Event id
- 99045
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