FDAFDA · Food and drugs·Recall number Z-3053-2018
Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 440 mm, Item Number: 814309440
Published September 19, 2018 · Recall initiated: July 17, 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
- The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.
- Lot
- 814090 899810
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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