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U.S. Department of Health and Human Services

Class 2 Device Recall CORE

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  Class 2 Device Recall CORE see related information
Date Initiated by Firm August 05, 2005
Date Posted August 23, 2005
Recall Status1 Terminated 3 on October 26, 2005
Recall Number Z-1390-05
Recall Event ID 32845
510(K)Number K040369  
Product Classification Driver, Wire, And Bone Drill, Manual - Product Code DZJ
Product Stryker brand Consolidated Operating Room Equipment (CORE) SystemPowered Instrument Driver, REF 5400-50; Model 5400-050-000A.
Code Information All units manufactured June 23, 2005 through July 22, 2005.
Recalling Firm/
Stryker Instruments Div. of Stryker Corporation
4100 E. Milham
Kalamazoo MI 49001
For Additional Information Contact Jennifer Mars
800-800-4236 Ext. 3808
Manufacturer Reason
for Recall
Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current.
FDA Determined
Cause 2
Action U.S. customer was notified via recall letter dated August 5, 2005 and international affiliates were notified via email. U.S. account was requested to return the product.
Quantity in Commerce 27
Distribution Virginia, Australia, Canada, England, France, Germany, Japan, Netherlands, Sweden, Switzerland,
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 = DZJ and Original Applicant = STRYKER INSTRUMENTS