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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 Recall
iLink Bone Void Filler
see related information
Date Posted September 03, 2009
Recall Status1 Open
Recall Number Z-1965-2009
Recall Event ID 52798
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, Ohio 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.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
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