Recall Z-1193-2017 ยท OLO Orthopedic Stereotaxic Instrument
Mako Surgical Corporation
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.
| Date | Sep 29, 2016 |
| Status | Terminated |
| Reason | Failure of the Offset Cup Reamer Handle not engaging its mating components. |
| Root cause | Component change control |
| Action | 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 |
| Quantity | 595 units |
| 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, Th |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121064 | MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM Mako Surgical Corporation, Jun 6, 2012 |