FDA recall Z-1475-2019

Product

Drill, cannulated, 4x150mm, AO, Item Number ST502015403

Reason for recall

An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Distribution

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

Key facts

Status

Terminated

Initiation date

2019-04-08

Report date

2019-05-29

Termination date

2020-05-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Winterthur, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1475-2019