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Recall Observatory FDA recall evidence

Device product

CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE Orthopedic

Z-2602-2014

July 30, 2014

Class II

Product summary

Firm
Wright Medical Technology, Inc.
Event
Event 69058
Status
Terminated
Classification
Class II
Quantity
1127 units
Official record key
device-enforcement:Z-2602-2014

Official wording

Reason: Plates manufactured from an incorrect raw material.

Code information: Lot Numbers: 1490004, 1490005, 1490199, 1490200, 1490201, 1490202, 1518483, 1519493, 1519494, 1519495, 1522021, 1522898, 1522899, 1522900, 1523735, 1523736, 1526519, 1526520, 1526521, 1538760, 1538761, 1539402, 1540715, 1540716, 1540717, 1542703, 1542704, 1542776, 1543491, 1543891

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.