Z-0447-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 21, 2018
- Initiation Date
- October 2, 2018
- Termination Date
- June 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,163 in total (expanded)
Product Description
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.
Reason for Recall
The set screw is not able to advance or reverse from the original position in the nail.
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.
Code Information
Lot number 371540