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Recall Observatory FDA recall evidence

Device product

CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONLY, NON STERILE Orthopedic

Z-2603-2014

July 30, 2014

Class II

Product summary

Firm
Wright Medical Technology, Inc.
Event
Event 69058
Status
Terminated
Classification
Class II
Quantity
400 units
Official record key
device-enforcement:Z-2603-2014

Official wording

Reason: Plates manufactured from an incorrect raw material.

Code information: Lot Numbers: 1490367, 1490368, 1512152, 1521232, 1523734, 1523746, 1537160, 1537161, 1539401, 1541613, 1541614, 1542652, 1542774, 1542775

Distribution pattern: Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Plates manufactured from an incorrect raw material.