FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: Stryker MIS Bur, 3.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-135.
- Recall number
- Z-0598-2010
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- Stryker MIS Bur, 3.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-135.
- Status
- Terminated
- Initiated
- 2009-07-06
- Posted
- 2010-01-11
- Terminated
- 2010-10-25
- Reason
- The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both.
- 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
- 5438 of all products
- Distribution
- Nationwide distribution: Australia, Canada, England, France, Hong Kong, Japan, Netherlands, South Africa, Sweden, Switzerland and Taiwan.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K032303","K040300"]
- PMA numbers
- not on file
- Product code
- HBE
- 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