ClearanceBrief
Recall Z-1572-2026 ยท OLO Orthopedic Stereotaxic Instrument

Howmedica Osteonics Corp.

MICS3 Angled Sagittal Saw Attachment; Part Number: 210490

DateMar 18, 2026 (initiated Feb 2, 2026)
StatusOpen, Classified
ReasonA potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment.
Root causeUnder Investigation by firm
ActionOn February 2, 2026 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 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. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and return via email. 4. Please contact your Local Sales Office or your Stryker Sales Represe
Quantity1098 units
DistributionDomestic: Nationwide Distribution; International: Australia, Germany, Belgium, France, Spain UK, New Zealand;
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K220459Mako Total Knee Application
Mako Surgical Corp., Apr 15, 2022
K241011Mako Total Knee Application
Mako Surgical Corp., Jun 11, 2024