Recall Z-1823-2019 ยท OLO Orthopedic Stereotaxic Instrument
Mako Surgical Corporation
2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
| Date | Apr 25, 2019 |
| Status | Terminated |
| Reason | The bearings of the saw attachments were ungreased. |
| Root cause | Under Investigation by firm |
| Action | On April 25, 2019, URGENT MEDICAL DEVICE RECALL letters under Stryker's letterhead were sent to their US consignees advising them of the issue, potential harm. This letter instructed their consignees to inform users of this device of the recall, requested that they complete the enclosed URGENT MEDICAL DEVICE RECALL BUSNESS REPLY FORM, and return all recalled product to Stryker. Actions to be taken by the Customer/ User: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization. 2. Hospitals/Branc |
| Quantity | 39 |
| Distribution | AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143752 | Total Knee Application (TKA) Mako Surgical Corp., Aug 6, 2015 |