Z-0598-2010

Stryker MIS Bur, 3.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-135

Name: Z-0598-2010 Stryker MIS Bur, 3.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-135
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2009-07-06
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2009-07-06 / Terminated / root cause: design

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker MIS Bur, 3.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-135 on 2009-07-06. The reason FDA records is "The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0598-2010
Status: Terminated
Initiated: 2009-07-06
Posted: 2010-01-11
Terminated: 2010-10-25
Recalling firm: Stryker Corp.
Product: Stryker MIS Bur, 3.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-135.
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Reason for recall: The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were sent a letter dated 7/10/09 instructing them to locate and return product on hand for replacement. Surgeons who use the product were notified via a separate, untitled letter, dated July 13, 2009. A speed warning will be added to the product labels. Questions are directed to the firm at: 1-800-800-4236 ext. 3808.
Quantity in commerce: 5438 of all products
Distribution: Nationwide distribution: Australia, Canada, England, France, Hong Kong, Japan, Netherlands, South Africa, Sweden, Switzerland and Taiwan.
Product codes and lots: All lots distributed 1/30/06 through 3/4/09. Lots 05363017, 06037017, 06069027, 06094017, 06165017, 06240017, 06275017, 06305017, 06354017, 07029017, 07079017, 07080017, 07108017, 07143017, 07219017, 07233017, 07290017, 07333017, 08021017, 08038017, 08049017, 08098017, 08155017, 08156017, 08253017, 08337017 and 09054017.

Product code HBE

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)