Zimmer, Inc.: Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
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 Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
- 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. 110040240 ; UDI-DI (01)00889024681965(17)350601(10)099457 ; Lot Number 099457 Model No. 110040240 ; UDI-DI (01)00889024681965(17)350712(10)099458 ; Lot Number 099458
- Product quantity
- 474 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Warsaw
- State
- IN
- Country
- United States
- Event id
- 99045
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