Device product
Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Product Usage: The Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
Z-2099-2013
Product summary
- Event
- Event 65891
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23 units
- Official record key
device-enforcement:Z-2099-2013
Official wording
Reason: Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect.
Code information: Catalog # 604640, Lot Code R11428 21 units Catalog # 604642S, Lot Code R09071 1 unit
Distribution pattern: USA Nationwide Distribution in the states of: FL. OH, TX, & VA
Derived failure modes
-
Unknown
Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect.