FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF 2296-101-621.
- Recall number
- Z-0263-2010
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF 2296-101-621.
- Status
- Terminated
- Initiated
- 2009-10-05
- Posted
- 2009-11-16
- Terminated
- 2009-11-30
- Reason
- The cross-cuts are missing on the device, which will result in poor cutting and overheating and/or smoking of the device.
- Root cause
- Vendor change control
- Action
- Consignees were notified by letter dated 10/5/09 and requested to return the devices to Stryker. The international account was notified by email.
- Quantity
- 93
- Distribution
- USA (California, Georgia, Louisiana, Ohio, Wisconsin) and Brazil.
- Lot, serial or model codes
- Lots 08311017 and 08336027.
- 510(k) numbers
- ["K040369"]
- PMA numbers
- not on file
- Product code
- DZI
- Firm FEI
- 1811755
- Firm city
- Kalamazoo
- 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