Device product
Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
Z-0447-2019
Product summary
- Event
- Event 81223
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,163 in total (expanded)
- Official record key
device-enforcement:Z-0447-2019
Official wording
Reason: The set screw is not able to advance or reverse from the original position in the nail.
Code information: Lot number 371540
Distribution pattern: Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico; and foreign countries of: Chile, Costa Rica, Ecuador and Netherlands.
Derived failure modes
-
Unknown
The set screw is not able to advance or reverse from the original position in the nail.