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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Instruments 2.1 mm CrossCut Fissure Bur

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  Class 2 Device Recall Stryker Instruments 2.1 mm CrossCut Fissure Bur see related information
Date Initiated by Firm October 05, 2009
Date Posted November 16, 2009
Recall Status1 Terminated 3 on November 30, 2009
Recall Number Z-0263-2010
Recall Event ID 53549
510(K)Number K040369  
Product Classification drill - Product Code DZI
Product Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF 2296-101-621.
Code Information Lots 08311017 and 08336027.
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E. Milham Ave.
Kalamazoo MI 49001
For Additional Information Contact
269-323-7700 Ext. 3808
Manufacturer Reason
for Recall		 The cross-cuts are missing on the device, which will result in poor cutting and overheating and/or smoking of the device.
FDA Determined
Cause 2		 Vendor change control
Action Consignees were notified by letter dated 10/5/09 and requested to return the devices to Stryker. The international account was notified by email.
Quantity in Commerce 93
Distribution USA (California, Georgia, Louisiana, Ohio, Wisconsin) and Brazil.
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 = DZI and Original Applicant = STRYKER INSTRUMENTS
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