Device product
CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW, REF 4013-0130, 1 EACH, Rx ONLY, NON STERILE Orthopedic
Z-2600-2014
Product summary
- Event
- Event 69058
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 units
- Official record key
device-enforcement:Z-2600-2014
Official wording
Reason: Plates manufactured from an incorrect raw material.
Code information: Lot Number: 1509955
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.