FDA recall Z-3081-2018

Product

Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 320 mm, Item Number: 814409320

Reason for recall

The set screw is not able to advance or reverse from the original position in the nail.

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.

Key facts

Status

Terminated

Initiation date

2018-07-17

Report date

2018-09-19

Termination date

2020-06-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3081-2018