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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-0311-2008
Recall Event ID 45461
510(K)Number K030608  
Product Classification Bone Plug - Product Code JDK
Product VariLift Bone Plug w/ End Cap; 15mm Dia, 24mm long; Ref #: CIE1-15-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.
Code Information Lot #: 122CIE1-15-24-BP, 291C, T179, T184, T412, T416, T425, 2950, 53845879, 53852082, X117 and X118.
Recalling Firm/
Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact
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 56 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.