← FDA ENFORCEMENT
Z-2531-2026Class II

Zimmer, Inc.

Recalling firm
Zimmer, Inc.
Product type
Device
Status
Ongoing
Report date
2026-07-01
Distribution
US Nationwide distribution.
Firm state
IN
Product quantity
13 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

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

Product description

Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476

Code / lot info

Lot Code: Model No. 110040476 ; UDI-DI (01)00889024682047(17)350531(10)097492 ; Lot Number 097492

Other recalls SPEQ maps to Risk Management & CAPA
2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.
See all Risk Management & CAPA recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.