Recall Z-0829-2015 ยท OLO Orthopedic Stereotaxic Instrument
Mako Surgical Corporation
RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
| Date | Dec 18, 2014 (initiated Oct 7, 2014) |
| Status | Terminated |
| Reason | MAKO has identified the potential that the shell impactors may be damaged intraoperatively. |
| Root cause | Device Design |
| Action | MAKO Surgical Corporation sent an Important Medical Device Recall Notice dated October 7, 2014, to all affected customers. The letter identified the product, the problem, and hte action to be taken by the customer. Customers were instructed to review their inventory for the affected product and return affected inventory to MAKO, Ft. Lauderdale. Customers were instructed to provide the Recall Notification to all field personnel to enhance awareness of the event. Customers were instructed to complete the attached acknowledgement form indicating receipt of the notice. Customers were asked to |
| Quantity | Total 404 |
| Distribution | Nationwide Distribution including IL, OH, AZ, CO, GA, OK, NC, VA, CT, FL, CA, MA, NY, MI, VA, NH, TX, LA, WA, NJ, CA, RI, ID, TN, IN, WA, PA, and WI. |
| 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 |