FDA Medical Device Recalls (openFDA)
Stryker Corporation: stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
- Recall number
- Z-1138-2025
- Recalling firm
- Stryker Corporation
- Product
- stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
- Status
- Open, Classified
- Initiated
- 2025-01-08
- Posted
- 2025-02-11
- Terminated
- not on file
- Reason
- Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
- Root cause
- Process control
- Action
- Stryker issued an URGENT MEDICAL DEVICE recall notice to its consignees on 01/08/2025 via FedEx. The notice explained the issue, potential risk, and requested the affected items be quarantined pending return. Stryker will issue a shipping label to the consignee once the response form has been received. Distributors were directed to forward the notice to all those to whom the affected devices were distributed.
- Quantity
- 622 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- GTIN 04546540046482, Lot Number 22298017
- 510(k) numbers
- ["K143145"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3015967359
- Firm city
- Portage
- Firm state
- MI
- 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