—#218642

Product

MICS3 Angled Sagittal Saw Attachment; Part Number: 210490

FDA product code: OLO — Orthopedic Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K220459, K241011
Affected lot / code info: Part Number: 210490; UDI: (01)07613327523874(10)TU6563205RP; Lot numbers: ALL;

Why it was recalled

A 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 cause (FDA determination)

Under Investigation by firm

Action the firm took

On 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 Representative directly for product replacement and inventory questions. 5. Please return the devices to Stryker using the address provided.

Recalling firm

Firm: Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: Domestic: Nationwide Distribution; International: Australia, Germany, Belgium, France, Spain UK, New Zealand;

Timeline

Recall initiated: 2026-02-02
Posted by FDA: 2026-03-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218642. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.