FDAFDA · Food and drugs·Recall number Z-3157-2018
Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 360 mm, Item Number: 814611360
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
- 017730 085400 154660 154670 154680 157450 558510 565960 694270 711210 812570 812730 818350 945040 629800
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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