Class 2 Device Recall CORE

• Date Initiated by Firm: August 05, 2005
• Date Posted: August 23, 2005
• Recall Status: Terminated on October 26, 2005
• Recall Number: Z-1389-05
• 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) System Powered Instrument Driver, REF 5400-50; Model 5400-050-000.
• Code Information: All units manufactured July 22, 2005 through July 25, 2005.
• Recalling Firm/ Manufacturer: 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: Other
• 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: 25
• 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