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Recall Observatory FDA recall evidence

Device product

CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE Orthopedic

Z-2601-2014

July 30, 2014

Class II

Product summary

Firm
Wright Medical Technology, Inc.
Event
Event 69058
Status
Terminated
Classification
Class II
Quantity
497 units
Official record key
device-enforcement:Z-2601-2014

Official wording

Reason: Plates manufactured from an incorrect raw material.

Code information: Lot Numbers: 1487673, 1487674, 1487675, 1487676, 1490003, 1512150, 1512151, 1519497, 1519498, 1522019, 1522020, 1523747, 1523748, 1537072, 1537073, 1537162, 1539399, 1541615, 1541616, 1543148, 1543149

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.