Z-0918-2018 Class II Terminated
FDA device recall Z-0918-2018 was initiated by Zimmer Biomet, Inc. on October 3, 2017 and is designated Class II. 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. The recall status is terminated (terminated August 20, 2018). Affected quantity: 457.
Recall Details
- Product Type
- Devices
- Report Date
- March 14, 2018
- Initiation Date
- October 3, 2017
- Termination Date
- August 20, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 457
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.
Distribution Pattern
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.
Code Information
All lots