Device product
CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Right, REF CCP-LPX1R. Orthopedic use.
Z-1487-2015
Product summary
- Event
- Event 70859
- Status
- Terminated
- Classification
- Class II
- Quantity
- 142 units
- Official record key
device-enforcement:Z-1487-2015
Official wording
Reason: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
Code information: Lot Numbers: 35049-7A, 35049-7A-1, 362832, 36283-2-2
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Potency or specification failure
out of specification