FDAHealthMay 20, 2026
Zimmer, Inc. — Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
⚠️ Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 20, 2026
US Nationwide distribution.
What's affected?
- Product
- Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
- Brand
- Zimmer, Inc.
- Lot code
- Model
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 474 units.
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