PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: March 14, 2018 Initiated: October 3, 2017 #Z-0918-2018

Product Description

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.

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
457
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.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04. Recalled by Zimmer Biomet, Inc.. Units affected: 457.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 14, 2018. Severity: Moderate. Recall number: Z-0918-2018.