FDA
Food and Drug Administration · Recall Z-2528-2026 · May 20, 2026Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Zimmer, Inc.
The hazard
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Lot Code: Model No. 110040241Model UDI-DI (01)00889024681941(17)350602(10)099463Model Lot Number 099463 Model No. 110040241Model UDI-DI (01)00889024681941(17)350531(10)099464Model Lot Number 099464 Model No. 110040241Model UDI-DI (01)00889024681941(17)350812(10)099465Model Lot Number 099465 Model No. 110040241Model UDI-DI (01)00889024681941(17)350707(10)099467Model Lot Number 099467UPC 00889024681941Would you have heard about this one?
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