FDA Medical Device Recalls (openFDA)
Howmedica Osteonics Corp.: MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
- Recall number
- Z-1572-2026
- Recalling firm
- Howmedica Osteonics Corp.
- Product
- MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
- Status
- Open, Classified
- Initiated
- 2026-02-02
- Posted
- 2026-03-18
- Terminated
- not on file
- 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.
- 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
- 1098 units
- Distribution
- Domestic: Nationwide Distribution; International: Australia, Germany, Belgium, France, Spain UK, New Zealand;
- Lot, serial or model codes
- Part Number: 210490; UDI: (01)07613327523874(10)TU6563205RP; Lot numbers: ALL;
- 510(k) numbers
- ["K220459","K241011"]
- PMA numbers
- not on file
- Product code
- OLO
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28