FDA recall Z-2339-2018

Product

Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile

Reason for recall

Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation of function with the adapter collar sticking, and/or not retaining the mating adapter male shaft.

Distribution

U.S. States: NE, MA, GA, TX, OR, AZ, FL, OH, WA, NJ, UT, VA, CA, MN, PA, DE, OK, KS, WI, MT, IA, MO

Key facts

Status

Terminated

Initiation date

2018-03-27

Report date

2018-07-11

Termination date

2020-06-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2339-2018