Device product
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Z-2604-2014
Product summary
- Event
- Event 69058
- Status
- Terminated
- Classification
- Class II
- Quantity
- 178 units
- Official record key
device-enforcement:Z-2604-2014
Official wording
Reason: Plates manufactured from an incorrect raw material.
Code information: Lot Numbers: 1487670, 1487671, 1487672, 1512149, 1519496, 1523745, 1534796, 1537159, 1539400, 1540714
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.