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U.S. Department of Health and Human Services

Class 2 Device Recall VariLift Bone Plug

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  Class 2 Device Recall VariLift Bone Plug see related information
Date Initiated by Firm September 19, 2007
Date Posted January 09, 2008
Recall Status1 Terminated 3 on March 10, 2008
Recall Number Z-0309-2008
Recall Event ID 45461
510(K)Number K030608  
Product Classification Bone Plug - Product Code JDK
Product VariLift Bone Plug w/ End Cap; 11mm Dia, 24mm long; Ref #: CIE1-11-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.
Code Information Lot #: 122CIE1-11-24-BP, 2245, 2250, 2260, 2535, 2545, 2940, U051, U748 and W657.
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact
512-834-6235
Manufacturer Reason
for Recall		 Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....)
FDA Determined
Cause 2		 Labeling Change Control
Action The recalling firm notified consignees of its recall via an Urgent Device Recall letter on 09/19/07. Consignees notified of a labeling error regarding device usage and were told they would be notified by a customer service rep to facilitate return of the recalled devices.
Quantity in Commerce 40 units.
Distribution Nationwide: including direct accounts in CO, KS and TX.
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 = JDK and Original Applicant = OSTEOIMPLANT TECHNOLOGY, INC.
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