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.
Reported: November 21, 2018 Initiated: October 2, 2018 #Z-0449-2019
Product Description
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.
Reason for Recall
The set screw is not able to advance or reverse from the original position in the nail.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 2,163 in total (expanded)
- Distribution
- 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.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Zimmer Biomet, Inc.. Units affected: 2,163 in total (expanded).
Why was this product recalled? ▼
The set screw is not able to advance or reverse from the original position in the nail.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 21, 2018. Severity: Moderate. Recall number: Z-0449-2019.
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