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U.S. Department of Health and Human Services

Class 2 Device Recall ZeroP StarDrive Screwdriver Shaft

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  Class 2 Device Recall ZeroP StarDrive Screwdriver Shaft see related information
Date Initiated by Firm February 10, 2009
Date Posted June 10, 2009
Recall Status1 Terminated 3 on October 05, 2009
Recall Number Z-1348-2009
Recall Event ID 51781
510(K)Number K072981  
Product Classification screwdriver instructions - Product Code ODP
Product Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion surgery. Catalog # 03.617.902 Technique Guide.
Code Information Catalog # 03.617.902 - All lots
Recalling Firm/
Manufacturer		 Synthes Spine
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Ed Hung
610-719-5865
Manufacturer Reason
for Recall		 Tip breakage, due to inadequate instructions for use. The Technique Guide provided incorrect information related to use of the Torque Limiting Attachment during screw insertion and final tightening.
FDA Determined
Cause 2		 Labeling design
Action All affected Synthes Spine Sales Consultants were notified of the Labeling Correction via email on February 10, 2009. They were instructed to review changes with their surgeons. They were supplied with an electronic version of the corrected Technique Guide on March 11, 2009. All affected Synthes Sales Consultants and Customers were notified of this labeling change via distribution of the updated Technique Guide and a notification letter. This packet was sent via USPS certified mail on March 26, 2009. To ensure a broad and accurate distribution of notification, affected consultants and customers are defined as having been shipped Zero-P 3.0 mm Titanium Cervical Spine Locking Screws. These devices are used only with the Zero-P system.
Quantity in Commerce 1766 units
Distribution Distributed Nationwide and Canada.
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 = ODP and Original Applicant = SYNTHES SPINE CO.LP
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