Recall Z-2745-2020 ยท OLO Orthopedic Stereotaxic Instrument
Mako Surgical Corporation
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
| Date | Jul 31, 2020 (initiated Jul 9, 2020) |
| Status | Terminated |
| Reason | Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures. |
| Root cause | Under Investigation by firm |
| Action | On July 09, 2020, Stryker's issued urgent medical device recall. The following actions were instructed in the recall notification. 1.Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3.Quarantine and discontinue use of the recalled devices identified in the affected product list. Return the devices back to Stryker. 4.Hospitals/Branches/Agencies: Complete and sign the |
| Quantity | 12 units |
| Distribution | TX, MN, CA, RI, FL, NY, AZ, TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141989 | MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM Mako Surgical Corporation, Nov 13, 2014 |