FDA recall Z-0146-2019

Zimmer Biomet, Inc. · Class II · device

Product

Affixus Hip Fracture Nail Left 125 9 mm x 300 mm, Item Number 814409300 Product Usage: Intended for the fixation of fractures

Reason for recall

There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

Distribution

Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY. The products were distributed to the following foreign countries: Chile, Netherlands.

Key facts

Status
Terminated
Initiation date
2018-08-08
Report date
2018-10-24
Termination date
2020-07-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0146-2019