Device product
RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223
Z-1024-2017
Product summary
- Event
- Event 75970
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36
- Official record key
device-enforcement:Z-1024-2017
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-108323 Lot 761680 UDI (01)00880304651524(17)210713(10)761680 Item XL-108223 Lot 419460 UDI (01)00880304651494(17)210713(10)419460
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.