FDA
Food and Drug Administration · Recall Z-2527-2026 · May 20, 2026Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
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 Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
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. 110040240Model UDI-DI (01)00889024681965(17)350601(10)099457Model Lot Number 099457 Model No. 110040240Model UDI-DI (01)00889024681965(17)350712(10)099458Model Lot Number 099458UPC 00889024681965Would you have heard about this one?
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