Device product
CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Right, REF CCP-LPX0R. Orthopedic use.
Z-1485-2015
Product summary
- Event
- Event 70859
- Status
- Terminated
- Classification
- Class II
- Quantity
- 102 units
- Official record key
device-enforcement:Z-1485-2015
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: 35049-31A-1, 35049-3A, 35049-3A-1-1, 362812, 36281-2-1
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Potency or specification failure
out of specification