Z-1193-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 22, 2017
- Initiation Date
- September 29, 2016
- Termination Date
- August 6, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 595 units
Product Description
Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.
Reason for Recall
Failure of the Offset Cup Reamer Handle not engaging its mating components.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WV, & WY and the countries of Italy, Germany, Australia, China, Europe, Hong Kong, South Africa, Germany, Thailand & Singapore.
Code Information
All lots recalled, Catalog No. 207080.