Device product
Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
Z-1025-2017
Product summary
- Event
- Event 75970
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19
- Official record key
device-enforcement:Z-1025-2017
Official wording
Reason: Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.
Code information: Item XL-200152 Lot 339260 UDI (01)00880304491366(17)210713(10)339260
Distribution pattern: USA (nationwide) and Internationally to ARGENTINA
Derived failure modes
-
Unknown
Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.