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U.S. Department of Health and Human Services

Class 3 Device Recall FormPutty Bone Void Filler 10cc

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 Class 3 Recall
FormPutty Bone Void Filler 10cc
see related information
Date Posted September 18, 2008
Recall Status1 Open
Recall Number Z-2375-2008
Recall Event ID 49018
Premarket Notification
510(K) Number
K053228 
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
Product FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in a box following sterilization. Part # 50-07-0100 Is a flowable resorbable porous bone void filler composed of beta tricalcium phosphate and other calcium phosphates.
Code Information Lot # A08F01E Exp Date 2010-06
Recalling Firm/
Manufacturer
Theken Spine LLC
1800 Triplett Blvd
Akron, Ohio 44306-3311
For Additional Information Contact Suzanne Wojcik
330-475-8643
Manufacturer Reason
for Recall
The patient label inside the package has an expiration date of 2008-06 when the actual expiration date is 2010-06.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action In a letter dated July 11, 2008, the firm asked their customers to check their inventory for the suspect product. If found they are to return the product for credit or replacement. The firms asks customers to contact them if any units were used for surgery and they will send the correct patient labels. If additional information is needed, customers are to contact Theken Spine Regulatory Affairs or the Quality Department.
Quantity in Commerce 33 syringes
Distribution Nationwide Distribution --- including states of FL, OH, TX, and UT.
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
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQV and Original Applicant = THERICS, LLC
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