FDAFDA · Food and drugs·Recall number Z-3047-2018
Affixus¿ Hip Fracture Nail 125¿ 9 mm x 180 mm, Item Number: 814309180
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
- 017090 017100 017110 017120 063130 063190 188050 188080 188090 219720 219730 219740 219750 290520 290550 331360 371020 371060 455870 455890 530040 530060 530080 541100 559250 559260 559270 559290 688160 706780 899800 944420 530030 530090
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.