Recall Z-1588-2016 ยท OLO Orthopedic Stereotaxic Instrument
Mako Surgical Corporation
MAKOplasty Hip Array Kit Laminate 150230
| Date | Nov 25, 2015 |
| Status | Terminated |
| Reason | Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table. |
| Root cause | Component change control |
| Action | On 12/09/2015, Product Field Action Letters and Product Accountability forms were sent to Branch/Agencies via overnight courier with a return receipt; Hospital Risk Management were sent Notification letters and a Product Recall Acknowledgement form with return receipt on 12/9;/2015. |
| Quantity | 10 units. |
| Distribution | CO, KY, MN, WA and WV |
| 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 |