FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: Stryker MIS Bur, 3.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-130.
- Recall number
- Z-0597-2010
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- Stryker MIS Bur, 3.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-130.
- 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 06004017, 06034017, 06037017, 06037027, 06093017, 06165017, 06177017, 06353017, 07017017, 07046017, 07092017, 07095017, 07109017, 07143017, 07205017, 07233017, 07242017, 07248017, 07260017, 07316017, 07344017, 07351017, 08022017, 08030017, 08042017, 08051017, 08081017, 08108017, 08115017, 08133017, 08140017, 08155017, 08182017, 08210017, 08233017, 08255017, 08290017, 08296017, 08323017, 08357017 and 09040017.
- 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