← FDA ENFORCEMENT
Z-2529-2026Class 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
429 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, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242

Code / lot info

Lot Code: Model No. 110040242 ; UDI-DI (01)00889024681989(17)350601(10)099471 ; Lot Number 099471 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350614(10)099473 ; Lot Number 099473 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350804(10)099474 ; Lot Number 099474 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350806(10)099475 ; Lot Number 099475

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.