FDA recall Z-0517-2020

Product

ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp, Model Number 110032331

Reason for recall

The potential that the end of the shaft could fail to effectively mate with the broach with the Calcar Planar Shaft instrument, part number 110032331.

Distribution

CA, IN, MN, NJ, NY, AR, LA, OH, KY, TX, CO (US) CA, CN, NL (International)

Key facts

Status

Terminated

Initiation date

2019-08-06

Report date

2019-12-04

Termination date

2020-08-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0517-2020