MICS3 Angled Sagittal Saw Attachment recallZ-1572-2026 · Howmedica Osteonics Corp. · initiated Feb 2, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1572-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 2, 2026
- Posted by the FDA
- Mar 18, 2026
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 1098 units
- Product code
- OLO
- FDA submissions
- K220459, K241011
- Distribution
- Domestic: Nationwide Distribution; International: Australia, Germany, Belgium, France, Spain UK, New Zealand;
Product description
MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
Code information (models, lots, serial numbers)
Part Number: 210490; UDI: (01)07613327523874(10)TU6563205RP; Lot numbers: ALL;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Mako 210490Mako Surgical Corp. · Orthopedic stereotaxic instrument1 recall9 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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