FDA recall Z-1310-2021

Arthrex, Inc. · Class II · device

Product

Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.

Reason for recall

The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.

Distribution

US Nationwide distribution in the states of Ohio, Oregon, Tennessee, Texas.

Key facts

Status
Terminated
Initiation date
2021-02-24
Report date
2021-04-07
Termination date
2023-05-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Naples, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1310-2021