Z-1003-2008

Stryker 4.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-40

Name: Z-1003-2008 Stryker 4.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-40
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2008-01-10
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2008-01-10 / Terminated / root cause: packaging

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker 4.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-40 on 2008-01-10. The reason FDA records is "Lack of assurance of sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1003-2008
Status: Terminated
Initiated: 2008-01-10
Posted: 2008-04-22
Terminated: 2009-12-01
Recalling firm: Stryker Corp.
Product: Stryker 4.0mm Round Fluted Bur, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-10-40.
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Reason for recall: Lack of assurance of sterility.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
Quantity in commerce: 10,588 of all products
Distribution: Worldwide Distribution - USA, Australia, Brazil, Canada, England, France, Germany, Hong Kong, India, Italy, Japan, Mexico, the Netherlands, New Zealand, Portugal, Saudi Arabia, Poland, Romania, South Africa, Spain, Sweden, Switzerland and United Arab Emirates.
Product codes and lots: All lots.

Product code HBE

K032303Class IIStryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments / cleared 2004-01-16

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)