FDA recall Z-0918-2018

Product

Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04

Reason for recall

The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the standard cleaning instructions potentially resulting in infection and subsequent complications.

Distribution

Distributed in 31 states: AL, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OR, PA, TN, TX, VA, VT, WA, WI and the District of Columbia.

Key facts

Status

Terminated

Initiation date

2017-10-03

Report date

2018-03-14

Termination date

2018-08-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0918-2018