PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: September 19, 2018 Initiated: July 17, 2018 #Z-3159-2018

Product Description

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

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
5947 total
Distribution
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.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 400 mm, Item Number: 814611400. Recalled by Zimmer Biomet, Inc.. Units affected: 5947 total.
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 September 19, 2018. Severity: Moderate. Recall number: Z-3159-2018.