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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker MIS Bur, 3.0mm Neuro Diamond

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 Class 2 Device Recall Stryker MIS Bur, 3.0mm Neuro Diamondsee related information
Date Initiated by FirmJuly 06, 2009
Date PostedJanuary 11, 2010
Recall Status1 Terminated 3 on October 25, 2010
Recall NumberZ-0597-2010
Recall Event ID 53982
510(K)NumberK032303 K040300 
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
ProductStryker MIS Bur, 3.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-130.
Code Information 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.
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E. Milham Ave.
Kalamazoo MI 49001
For Additional Information Contact
800-800-4236 Ext. 3808
Manufacturer Reason
for Recall		The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both.
FDA Determined
Cause 2		Device Design
ActionConsignees 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 Commerce5438 of all products
DistributionNationwide distribution: Australia, Canada, England, France, Hong Kong, Japan, Netherlands, South Africa, Sweden, Switzerland and Taiwan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HBE
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