Device product
CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use.
Z-1494-2015
Product summary
- Event
- Event 70859
- Status
- Terminated
- Classification
- Class II
- Quantity
- 233 units
- Official record key
device-enforcement:Z-1494-2015
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: 3504927, 35049-27A, 35049-27A-1, 35049-28, 362801, 36280-1-1, 8752-010381
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Potency or specification failure
out of specification