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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker MIS Bur, 2.5mm Neuro Diamond

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  Class 2 Device Recall Stryker MIS Bur, 2.5mm Neuro Diamond see related information
Date Initiated by Firm July 06, 2009
Date Posted January 11, 2010
Recall Status1 Terminated 3 on October 25, 2010
Recall Number Z-0596-2010
Recall Event ID 53982
510(K)Number K032303  K040300  
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
Product Stryker MIS Bur, 2.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-125.
Code Information All lots distributed 1/30/06 through 3/4/09. Lots 05363017, 06032017, 06065017, 06103017, 06179017, 07113017, 07143017, 07233017, 07291017, 07337017, 08007017, 08046017, 08107017, 08254017 and 09029017.
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
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HBE and Original Applicant = STRYKER INSTRUMENTS
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