← FDA ENFORCEMENT
Z-2527-2026Class 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
474 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 Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240

Code / lot info

Lot Code: Model No. 110040240 ; UDI-DI (01)00889024681965(17)350601(10)099457 ; Lot Number 099457 Model No. 110040240 ; UDI-DI (01)00889024681965(17)350712(10)099458 ; Lot Number 099458

Other recalls SPEQ maps to Risk Management & CAPA
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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.