FDA recall Z-1464-2019

Zimmer GmbH · Class II · device

Product

V-TEK", micro-countersink, round shaft, Item Number 28.66.112

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-1464-2019