Device product

Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240

Z-2527-2026

May 20, 2026

Class II

Product summary

Firm: Zimmer, Inc.
Event: Event 99045
Status: Ongoing
Classification: Class II
Quantity: 474 units
Official record key: device-enforcement:Z-2527-2026

Official wording

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

Code information: 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

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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