Recall Z-1411-2017 ยท OLO Orthopedic Stereotaxic Instrument
Mako Surgical Corporation
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
| Date | Dec 22, 2016 |
| Status | Terminated |
| Reason | Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides |
| Root cause | Labeling design |
| Action | Letter from Stryker dated 1/28/2017 was sent via USP Next Day Air with return receipt to all their customers. With the following actions; Inform users of this medical device correction and forwar this notice to all those individuals who need to be aware within your organization and return the attached Business Replay Form within 5 business days, to Fax 844-782-5561 or via e-mail to stykerortho4253@stericycle.com |
| Quantity | 777 |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |