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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self Tapping Shaft

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  Class 2 Device Recall Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self Tapping Shaft see related information
Date Initiated by Firm March 08, 2006
Date Posted May 06, 2006
Recall Status1 Terminated 3 on June 26, 2008
Recall Number Z-0849-06
Recall Event ID 35046
510(K)Number K974017  
Product Classification Screwdriver, Skullplate - Product Code GXL
Product Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self Tapping Shaft, Catalog Number 8001215

The 8001215 Screwdriver is a stainless steel part designed for use with cruciate-style screws in the firm''s TiMesh System. The product is sold in non-sterile, single unit packages. They are re-usable, and autoclavable.
Code Information TV 59965,  TV 59967
Recalling Firm/
Manufacturer		 Medtronic Neurosurgery
125 Cremona Dr
Goleta CA 93117-5503
For Additional Information Contact Jeffery Henderson
800-826-5603 Ext. 1770
Manufacturer Reason
for Recall		 Medtronic Neurosurgery has initiated this action because it was determined that two lots of the Modular Screwdriver Blade components may exhiibt burrs along the tips of the Screwdriver, which may prevent adequate engagement with the associated screws.
FDA Determined
Cause 2		 Other
Action Medtronic Neurosurgery sent a Sales Representative Notification letter to the applicable Medtronic Sales Representative by mail and fax on March 8, 2006. A Sales Representative Notification Letter was provided to each Medtronic Sales Representative who had received the product or is responsible for an account who has received the product. This letter informed the applicable Sales Representative of the action and instructed them how to complete the Sales Representative Customer Product Accountability Letter. A Sales Representative Customer Product Accountability Letter was provided to each Medtronic Sales Representative who has received the product or is responsible for an account who has received the product. This letter requests the current product status, i.e., has the product been used, discarded or will it be returned to Medtronic Neurosurgery. Each letter will be individualized for each customer indicating the specific catalog number(s), lot number(s) and quantity that were shipped to that customer. It is the firm''s intention to have the Sales Representative exchange all affected product with replacement product during this process.
Quantity in Commerce 60
Distribution The product was distributed to the following states: Florida, Illinois, New York, Pennsylvania, Tennessee
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 = GXL and Original Applicant = SOFAMOR DANEK USA,INC.
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