Device product
Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
Z-2530-2026
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 99045
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11 units
- Official record key
device-enforcement:Z-2530-2026
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: 110040444 ; UDI-DI (01)00889024681903(17)350531(10)097487 ; Lot Number 097487
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.