Device product
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Z-2528-2026
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 99045
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 435 units
- Official record key
device-enforcement:Z-2528-2026
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. 110040241 ; UDI-DI (01)00889024681941(17)350602(10)099463 ; Lot Number 099463 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350531(10)099464 ; Lot Number 099464 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350812(10)099465 ; Lot Number 099465 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350707(10)099467 ; Lot Number 099467
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.