Device product
CROSSCHECK(R) Plating system, Utility Plate, 3-Hole, REF CCP-UTN3. Orthopedic use.
Z-1495-2015
Product summary
- Event
- Event 70859
- Status
- Terminated
- Classification
- Class II
- Quantity
- 308 units
- Official record key
device-enforcement:Z-1495-2015
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: 3504929, 35049-29A, 35049-29A-1, 35049-30, 362802, 36280-2-2, 8752-010391
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Potency or specification failure
out of specification