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U.S. Department of Health and Human Services

Class 2 Device Recall Surgical drill guide

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 Class 2 Device Recall Surgical drill guidesee related information
Date Initiated by FirmSeptember 24, 2010
Date PostedOctober 26, 2010
Recall Status1 Terminated 3 on April 13, 2011
Recall NumberZ-0145-2011
Recall Event ID 56893
510(K)NumberK050438 
Product Classification neurological stereotaxic instrument - Product Code HAW
ProductVertex Max Drill Guide, Catalog Number 9732355, to be used with a Medtronic Computer-Assisted Surgery System to help assist with screw placement during spine procedures. To be used with a Medtronic Computer-Assisted Surgery System to help assist with screw placement during spine procedures.
Code Information Lot number 100526
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc
826 Coal Creek Circle
Louisville CO 80027-9710
For Additional Information Contact
720-890-3217
Manufacturer Reason
for Recall		Drill guide handle may detach unintentionally during use.
FDA Determined
Cause 2		Other
ActionMedtronic Navigation sent a "Product Correction Notification" letter dated September 22, 2010 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to set aside and do not use the Vertex Max Drill Guide 9732355, Lot Number 100526 and complete and return the Verification of Field Action Completion form via email: steve.murray@medtronic.com or fax: 720-890-3517. A Medtronic representative will contact the customer, visit their facility, remove the defective product, and provide a replacement Vertex Max Drill Guide that is correctly manufactured. For further information or if you have questions regarding use of the Vertex Max Drill Guide, please contact Medtronic Navigation Technical Services at 1-800-595-9709.
Quantity in Commerce8 units
DistributionWorldwide distribution: USA including states of DC, IN, PA, and VA and country of Japan.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HAW
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