Device product

Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242

Z-2529-2026

May 20, 2026

Class II

Product summary

Firm: Zimmer, Inc.
Event: Event 99045
Status: Ongoing
Classification: Class II
Quantity: 429 units
Official record key: device-enforcement:Z-2529-2026

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. 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

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.