Recall Z-0472-2021 ยท OLO Orthopedic Stereotaxic Instrument
Mako Surgical Corporation
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).
| Date | Nov 19, 2020 (initiated Oct 23, 2020) |
| Status | Completed |
| Reason | Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later). This issue may result in unsuccessful checkpoint verification when the Mako System attempts to verify the location of the saw blade prior to bone preparation. This issue may also cause a discrepancy during bone preparation in a Mako Total Knee or a Mak |
| Root cause | Under Investigation by firm |
| Action | The firm issued a recall notice by UPS 1-day air through Sterilcycle, Inc. on 10/23/2020. The notice provided the following: "Actions needed: 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 |
| Quantity | 367 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Australia, Japan, Korea, Netherlands, and Chile, and France, Germany Luxembourg, and UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142350 | PK J-HOOK Gyrus Acmi, Inc., Jan 8, 2015 |