Recall Z-2051-2018 ยท NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Mako Surgical Corporation
Restoris MCK Onlay Insert Extractor.
| Date | Jun 1, 2018 (initiated Jan 19, 2018) |
| Status | Terminated |
| Reason | Possible hinge pin disassociation from the Mako Onlay Insert Extractor. |
| Root cause | Under Investigation by firm |
| Action | Customers were initially notified on approximately 01/19/2018, and again notified when the recall was expanded on 04/25/2018. Instructions included to inform all applicable individuals within the organization that need to be notified, complete and return the Recall Notification Business Reply Form, and make arrangements for return all affected products on hand. On about 12/12/2018, Stryker expanded the scope of the recall to include two additional lot codes and notified customers via "URGENT MEDICAL DEVICE REMOVAL" letter. Instructions were the same as the original recall notification. |
| Quantity | 575 units total (400 US, 175 OUS) |
| Distribution | Distributed domestically to AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, WI. Distributed internationally to Australia, China, Italy, Netherlands, Singapore, South Africa, Taiwan, Turkey, United Kingdom. |
| 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 |