FDA Medical Device Recalls (openFDA)
Stryker Instruments: Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
- Recall number
- Z-1478-2022
- Recalling firm
- Stryker Instruments
- Product
- Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
- Status
- Open, Classified
- Initiated
- 2022-06-24
- Posted
- not on file
- Terminated
- not on file
- Reason
- There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to critical neurological or vascular structures.
- Root cause
- Process change control
- Action
- On June 24, 2022, the firm notified customers via Urgent Medical Device Recall Letters. Customers were instructed to locate and quarantine any affected products found in their inventory. Upon receiving the customer's completed response form, the firm will provide a shipping label to return any recalled product. Upon receipt of the recalled product, Stryker will contact the customer to arrange for replacement product.
- Quantity
- 543
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of Arizona, California, Florida, Georgia, Iowa, Michigan, Missouri, New Mexico, North Carolina, Ohio, Texas, Virginia and the countries of Canada, Netherlands, and Thailand.
- Lot, serial or model codes
- UDI-DI (GTIN): 07613327294910 Affected Lots: 22011017 21330017 20216017 20140017 20139027
- 510(k) numbers
- ["K143320"]
- PMA numbers
- not on file
- Product code
- HBE
- 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