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Recall Observatory FDA recall evidence

Device product

CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthopedic use.

Z-1497-2015

March 06, 2015

Class II

Product summary

Firm
Wright Medical Technology, Inc.
Event
Event 70859
Status
Terminated
Classification
Class II
Quantity
138 units
Official record key
device-enforcement:Z-1497-2015

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: 3504933, 35049-33A, 35049-33A-1, 35049-34, 362804, 36280-4-1-A

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification