Device product
CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF CCP-LPX2L. Orthopedic use.
Z-1488-2015
Product summary
- Event
- Event 70859
- Status
- Terminated
- Classification
- Class II
- Quantity
- 148 units
- Official record key
device-enforcement:Z-1488-2015
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: 35049-9A, 35049-9A-1, 36281-1-11, 362841, 36284-1-11
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Potency or specification failure
out of specification