Z-0263-2010

Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF 2296-101-621

Name: Z-0263-2010 Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF 2296-101-621
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2009-10-05
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2009-10-05 / Terminated / root cause: supplier

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF 2296-101-621 on 2009-10-05. The reason FDA records is "The cross-cuts are missing on the device, which will result in poor cutting and overheating and/or smoking of the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-0263-2010
Status: Terminated
Initiated: 2009-10-05
Posted: 2009-11-16
Terminated: 2009-11-30
Recalling firm: Stryker Corp.
Product: Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF 2296-101-621.
Product code: DZI Drill, Bone, Powered
Reason for recall: The cross-cuts are missing on the device, which will result in poor cutting and overheating and/or smoking of the device.
Root cause tag: supplier
FDA 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 in commerce: 93
Distribution: USA (California, Georgia, Louisiana, Ohio, Wisconsin) and Brazil.
Product codes and lots: Lots 08311017 and 08336027.

Product code DZI

K040369Class IIStryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments / cleared 2004-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)