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U.S. Department of Health and Human Services

Class 2 Device Recall iLink Bone Void Filler

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 Class 2 Device Recall iLink Bone Void Fillersee related information
Date Initiated by FirmAugust 26, 2008
Date PostedSeptember 03, 2009
Recall Status1 Terminated 3 on March 09, 2012
Recall NumberZ-1965-2009
Recall Event ID 52798
510(K)NumberK040134 
Product Classification Filler, bone void, calcium compound - Product Code MQV
ProductiLink 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.
FEI Number 3002498892
Recalling Firm/
Manufacturer		 Theken Spine LLC
1800 Triplett Blvd
Akron OH 44306-3311
For Additional Information ContactWayne 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 2		Error in labeling
ActionTheken 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 Commerce22 units
DistributionNationwide Distribution -- TX.
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 = MQV
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