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U.S. Department of Health and Human Services

Class 2 Device Recall TruFit

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  Class 2 Device Recall TruFit see related information
Date Initiated by Firm September 29, 2006
Date Posted December 30, 2006
Recall Status1 Terminated 3 on August 09, 2007
Recall Number Z-0440-2007
Recall Event ID 36521
510(K)Number K040047  
Product Classification Bone plug - Product Code MQV
Product TruFit CB Plug Size Code Red, 7mm; quantity 1; Part #605-001-03; product labeled as sterile; manufactured by OsteoBiologics, Inc., San Antonio, TX.
Code Information 051024-14 and 011-051024-14.
Recalling Firm/
Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
Manufacturer Reason
for Recall
Mis-packaging-product in the package may be a different size than indicated on the labeling.
FDA Determined
Cause 2
Action Firm notified customers of recall by letter sent via FedEx on 09/29/06.
Quantity in Commerce 32
Distribution Nationwide-Product distributed to distributors, sales reps and hospitals in AL, CA, FL, IL, NJ, NM, NY, PA, TX and UT.
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 = OSTEOBIOLOGICS, INC.