Device product
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.
Z-1193-2017
Product summary
- Event
- Event 76025
- Status
- Terminated
- Classification
- Class II
- Quantity
- 595 units
- Official record key
device-enforcement:Z-1193-2017
Official wording
Reason: Failure of the Offset Cup Reamer Handle not engaging its mating components.
Code information: All lots recalled, Catalog No. 207080.
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.
Derived failure modes
-
Unknown
Failure of the Offset Cup Reamer Handle not engaging its mating components.