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U.S. Department of Health and Human Services

Class 2 Device Recall Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device

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 Class 2 Recall
Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device
see related information
Date Posted February 18, 2011
Recall Status1 Terminated on November 07, 2012
Recall Number Z-1260-2011
Recall Event ID 57567
Premarket Notification
510(K) Number
K093845 
Product Classification Staple, Implantable - Product Code GDW
Product Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device Product Code STRAP25. Intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures, such as hernia repairs.
Code Information All Lots. Batch Numbers: CJM838,CJZ014, CJZ065, CJZ228, CJZ456, CJZ542, CJZ625, CJ6116, CJ6293, CJ6402, CJ6572, CJ6852, CJK043, CJK216, CJK330, CJK536, CJK659, CKM791, CKZ068, CKZ437, CKZ652, and CK6002.
Recalling Firm/
Manufacturer
Ethicon, Inc.
US Highway 22 West
Somerville, New Jersey 08876
For Additional Information Contact Iris Magalhaes
908-218-3044
Manufacturer Reason
for Recall
The Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device may have the potential for the sterile barrier to be compromised due to a defect in the packaging.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Ethicon sent Urgent Voluntary Product Recall letters dated, December 28, 2010, to their customers on December 29, 2010 via UPS. The letter identified the affected product and described the reason for recall. Customers are to discontinue use and sampling immediately. They are to return the product using the enclosed prepaid shipping label along with the enclosed business reply card regardless of whether they have any affected product or not. Customers should contact 1-877-551-7147 or speak to their manager if they have questions regarding this recall.
Quantity in Commerce 4,110
Distribution Worldwide Distribution -- USA and Canada.
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 = GDW and Original Applicant = ETHICON, INC.
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