Device product
CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R. Orthopedic use.
Z-1491-2015
Product summary
- Event
- Event 70859
- Status
- Terminated
- Classification
- Class II
- Quantity
- 301 units
- Official record key
device-enforcement:Z-1491-2015
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: 3504919, 35049-19A, 35049-19A-1, 35049-20, 362792
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Potency or specification failure
out of specification