Recall
FDAHealthMay 20, 2026

Zimmer, Inc. — Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241

⚠️ 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, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Lot code
Model

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 435 units.

View original FDA notice →

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