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FDAFDA · Food and drugs·Recall number Z-3159-2018

Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 400 mm, Item Number: 814611400

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
060780 154560 482790 530170 759190 797000 797020 812460 812540 759180
Risk classification
Class II
Area (FDA)
device
Country
United States

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