FDA Recall Open, Classified

MICS3 Angled Sagittal Saw Attachment; Part Number: 210490

Recall: Z-1572-2026 · Initiated February 2, 2026

Recall

Recall Number
Z-1572-2026
Event Number
98411
Firm
Howmedica Osteonics Corp.
FEI Number
3003070421
Product Code
OLO
Status
Open, Classified
Root Cause
Under Investigation by firm
Initiated
February 2, 2026
Posted
March 18, 2026
Address
325 Corporate Dr, Mahwah, NJ, 07430-2006

Description

MICS3 Angled Sagittal Saw Attachment; Part Number: 210490

Reason

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.

Action

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. ***Update 04/22/2026*** On April 2 ,2026 MEDICAL DEVICE RECALL UPDATE letters were sent to customers. To inform and list all known hazards and harms potentially associated with the noted issue below and list risk mitigation factors associated with the use of the product. Hazards Include: Foreign Object and Component Disassociation. Customer actions remained unchanged.

Distribution

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

Quantity

1098 units