Recall Z-0044-2025 ยท OLO Orthopedic Stereotaxic Instrument
Howmedica Osteonics Corp.
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
| Date | Oct 9, 2024 (initiated Aug 7, 2024) |
| Status | Open, Classified |
| Reason | Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces. |
| Root cause | Vendor change control |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 8/7/24 was sent to customers. Recommendations for patients treated with an impacted device: Patients treated with an affected product identified in Attachment 1 should continue to be followed per the normal protocol established by his or her surgeon(s). There are no recommended changes to the frequency of the standard follow-up care protocol. Actions Needed: Our records indicate that you may have received the affected product(s). It is Stryker s responsibility as the manufacturer to ensure that customers who may have received these af |
| Quantity | 897 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093425 | MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA Mako Surgical Corp., Feb 24, 2010 |