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

Medical DevicesSource: FDA (device) · Date: 2026-07-01

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Zimmer, Inc.
Product
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Reason / hazard
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2026-05-20
Code info
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
Product quantity
435 units
Voluntary mandated
Voluntary: Firm initiated
City
Warsaw
State
IN
Country
United States
Event id
99045
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