Device product
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Z-2601-2014
Product summary
- 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
Plates manufactured from an incorrect raw material.