Class 2 Device Recall iLink Bone Void Filler

• Date Initiated by Firm: August 26, 2008
• Date Posted: September 03, 2009
• Recall Status: Terminated on March 09, 2012
• Recall Number: Z-1965-2009
• Recall Event ID: 52798
• 510(K)Number: K040134
• Product Classification: Filler, bone void, calcium compound - Product Code MQV
• Product: iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010, Exp. 2010-04.
• Code Information: Model Number: 50-05-0010; Lot Number: A07D02B.
• Recalling Firm/ Manufacturer: Theken Spine LLC; 1800 Triplett Blvd; Akron OH 44306-3311
• For Additional Information Contact: Wayne A. Stripe; 330-475-8662
• Manufacturer Reason for Recall: Failure to label the product properly. Additionally, 15 pieces were reworked and the expiration date was misprinted as 2011-04 instead of the actual date of 2010-04.
• FDA Determined Cause: Error in labeling
• Action: Theken Spine, LLC contacted the Consignee August 26, 2008 via telephone and instructed them to inventory their stock and return affected product to the firm. For further questions, contact Theken Spine, LLC at 1-330-475-8662.
• Quantity in Commerce: 22 units
• Distribution: Nationwide Distribution -- 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 = MQV and Original Applicant = THERICS, INC.