Z-1193-2017 Class II Terminated
FDA device recall Z-1193-2017 was initiated by Mako Surgical Corporation on September 29, 2016 and is designated Class II. Reason for recall: Failure of the Offset Cup Reamer Handle not engaging its mating components. The recall status is terminated (terminated August 6, 2019). Affected quantity: 595 units.
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.