| Date Initiated by Firm | February 02, 2026 |
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| Date Posted | March 18, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1572-2026 |
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| Recall Event ID |
98411 |
| 510(K)Number | K220459 K241011 |
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| Product Classification |
Orthopedic stereotaxic instrument - Product Code OLO
|
| Product | MICS3 Angled Sagittal Saw Attachment;
Part Number: 210490 |
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| Code Information |
Part Number: 210490;
UDI: (01)07613327523874(10)TU6563205RP;
Lot numbers: ALL; |
| FEI Number |
3003070421
|
Recalling Firm/
Manufacturer |
Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
|
| For Additional Information Contact | Anum Bartolotta
954-928-0808 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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.
|
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| Quantity in Commerce | 1098 units |
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| Distribution | Domestic: Nationwide Distribution;
International: Australia, Germany, Belgium, France, Spain UK, New Zealand; |
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| Total Product Life Cycle | TPLC Device Report |
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|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = OLO
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