Official recall notice

FDA DeviceClass IINotable

FDA Recall: Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Numbe

Recall date
2026-07-01
FDA class
Class II

Why it was recalled

Hazard

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Product description

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Affected products

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

Verify with the official notice →
Share:

Related Recalls

2026-07-01 · FDA_DEVICE
FDA Recall: Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
Zimmer, Inc.
2026-07-01 · FDA_DEVICE
FDA Recall: Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
Zimmer, Inc.
2026-07-01 · FDA_DEVICE
FDA Recall: Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augme
Zimmer, Inc.
2026-07-01 · FDA_DEVICE
FDA Recall: Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number:
Zimmer, Inc.