Stryker Instruments Div. of Stryker Corporation Stryker MIS Bur, 2.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-120. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stryker MIS Bur, 2.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-120.
Brand
Stryker Instruments Div. of Stryker Corporation
Lot Codes / Batch Numbers
All lots distributed 1/30/06 through 3/4/09. Lots 06004017, 06034017, 06075017, 06086017, 06206017, 07002017, 07039017, 07067017, 07121017, 07219017, 07279017, 07320017, 07346017, 08007017, 08030017, 08044017, 08081017, 08205017, 08275017 and 09043017.
Products Sold
All lots distributed 1/30/06 through 3/4/09. Lots 06004017, 06034017, 06075017, 06086017, 06206017, 07002017, 07039017, 07067017, 07121017, 07219017, 07279017, 07320017, 07346017, 08007017, 08030017, 08044017, 08081017, 08205017, 08275017 and 09043017.
Stryker Instruments Div. of Stryker Corporation is recalling Stryker MIS Bur, 2.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-120. due to The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026