FDA
Food and Drug Administration · Recall Z-2529-2026 · May 20, 2026Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
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, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
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. 110040242Model UDI-DI (01)00889024681989(17)350601(10)099471Model Lot Number 099471 Model No. 110040242Model UDI-DI (01)00889024681989(17)350614(10)099473Model Lot Number 099473 Model No. 110040242Model UDI-DI (01)00889024681989(17)350804(10)099474Model Lot Number 099474 Model No. 110040242Model UDI-DI (01)00889024681989(17)350806(10)099475Model Lot Number 099475UPC 00889024681989Would you have heard about this one?
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