Device product
Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
Z-2529-2026
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
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.