FDAFDA · Food and drugs·Recall number Z-0449-2019
Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 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.
Published November 21, 2018 · Recall initiated: October 2, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The set screw is not able to advance or reverse from the original position in the nail.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- 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.
- Lot
- Lot number 157410 171840
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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