Recall Z-1132-2014 ยท NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Mako Surgical Corporation
Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restori
| Date | Mar 4, 2014 (initiated Jan 9, 2014) |
| Status | Terminated |
| Reason | The product may be mislabeled and could result in the incorrect implant being used. |
| Root cause | Error in labeling |
| Action | MAKO Surgical Corporation sent an Important Medical Device Recall Notice letter dated January 9, 2014 to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. The letter informed the customers that their MAKOplasty Sales Specialist will coordinate with them the return of the product that will be replaced at no charge. Customers were asked to sign and return the Acknowledgement form to MAKO Surgical using one of the following methods: Email, Fax or Mail. For questions, customers were instructed to call (954) 628-1721. For question |
| Quantity | 41 units |
| Distribution | Nationwide distribution including AZ, FL, HI, OH, MI, NC NH, WA, TX, WI, OK, CA, RI, LA, ID, IL, IN, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090763 | RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM Mako Surgical Corporation, Jun 17, 2009 |