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.
This recall has been terminated (originally issued September 29, 2016).
- Company
- Mako Surgical Corporation
- Recall Initiated
- September 29, 2016
- Terminated
- August 6, 2019
- Recall Number
- Z-1193-2017
- Quantity
- 595 units
- Firm Location
- Davie, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Failure of the Offset Cup Reamer Handle not engaging its mating components.
Distribution
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.
Lot / Code Info
All lots recalled, Catalog No. 207080.
Root Cause
Component change control
Action Taken
Customers were sent a recall notificaiton letter, dated 10/17/2016, addressing the reason for recall and the appropriate actions that should be taken by customers. Consignees are instructed to return any recalled product on hand to Stryker C/O Stericycle, 2670 Executive Dr. Suite A, Indianapolis, IN 46241, Attn RA 2016-083, RA 2016-119 - Event 8811. Consignees are also instructed to inform their users of this recall and forward the notice to affected individuals. A Business Reply Form was provided and is to be completed within 5 business days of receipt by consignees. Completed business reply forms are to be faxed to 855-620-5693 or emailed to strykerortho8811@stericycle.com.