Device product
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Z-2602-2014
Product summary
- 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
Plates manufactured from an incorrect raw material.