Atlas FDA

MICS3 Angled Sagittal Saw Attachment; Part Number: 210490

FDA device recall Z-1572-2026 · posted 2026-03-18 · Open, Classified

Recall details

Recalling firm
Howmedica Osteonics Corp.
Reason for recall
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 taken
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.
Root cause
Under Investigation by firm
Status
Open, Classified
Product code
OLO
Quantity affected
1098 units
Distribution
Domestic: Nationwide Distribution; International: Australia, Germany, Belgium, France, Spain UK, New Zealand;
Date initiated
2026-02-02
Date posted
2026-03-18
Location
Mahwah, NJ

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