Class 2 Device Recall VariLift Bone Plug

• Date Initiated by Firm: September 19, 2007
• Date Posted: January 09, 2008
• Recall Status: Terminated on March 10, 2008
• Recall Number: Z-0307-2008
• Recall Event ID: 45461
• 510(K)Number: K030608
• Product Classification: Bone Plug - Product Code JDK
• Product: VariLift Bone Plug w/ End Cap; 16mm Dia, 24mm long; Ref #: CEA1-16-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.
• Code Information: Lot #: U102.
• 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: 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: 6 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