FDA recall Z-0871-2020

Product

ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument

Reason for recall

Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach

Distribution

US Nationwide and Foreign: countries of Canada, CHINA, NETHERLANDS

Key facts

Status

Terminated

Initiation date

2019-12-19

Report date

2020-02-05

Termination date

2020-08-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0871-2020