Z-1572-2026Class II
MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
Howmedica Osteonics Corp / initiated 2026-02-02 / Open, Classified
Howmedica Osteonics Corp. began a recall of MICS3 Angled Sagittal Saw Attachment; Part Number: 210490 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-1572-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Howmedica Osteonics Corp
- Product
- MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
- Product code
- OLO Orthopedic Stereotaxic Instrument
- 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.
- FDA root cause
- Under Investigation by firm
- 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.
- Quantity in commerce
- 1098 units
- Distribution
- Domestic: Nationwide Distribution; International: Australia, Germany, Belgium, France, Spain UK, New Zealand;
- Product codes and lots
- Part Number: 210490; UDI: (01)07613327523874(10)TU6563205RP; Lot numbers: ALL;
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1572-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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