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U.S. Department of Health and Human Services

Class 2 Device Recall Strattice Reconstructive Tissue Matrix for Stoma Reinforcement

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  Class 2 Device Recall Strattice Reconstructive Tissue Matrix for Stoma Reinforcement see related information
Date Initiated by Firm July 13, 2011
Date Posted November 09, 2011
Recall Status1 Terminated 3 on March 04, 2013
Recall Number Z-0178-2012
Recall Event ID 60104
510(K)Number K070560  
Product Classification Mesh, surgical - Product Code FTM
Product LifeCell Strattice Reconstructive Tissue Matrix for Stoma Reinforcement
Catalog #0606008 (6 x 6 cm), 0808008 (8 cm x 8 cm), (0610008 ( 6 cm x 10 cm).

Intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.
Code Information The following lots begin with the letter 'S' 10664; 10665; 10666; 10667; 10668; 10670; 10671; 10672; 10678; 10679; 10680; 10683; 10684; 10685; 10686; 10688; 10689; 10690; 10691; 10698; 10700; 10701; 10702; 10777; 10778; 10780; 10838; 10844; 10845; 10847; 10848; 10851; 10863; 10864; 10866; 10867; 10871; 10872; 10875; 10877; 10896; and 10910.
Recalling Firm/
Manufacturer		 LifeCell Corporation
1 Millennium Way
Branchburg NJ 08876-3876
For Additional Information Contact Ms. Bonnie Samuel
908-947-1042
Manufacturer Reason
for Recall		 The use of Strattice for stoma reinforcement at the time of stoma creation is not within the product's cleared indications for use in the US market.
FDA Determined
Cause 2		 PMA
Action LifeCell began notifying their customers via phone on 7/13/2011. Recall Notice Letters and return response forms, dated July 12, 2011, were sent out on the same day. The letter identified the affected product and informed customers of the reason for the recall. Customers were asked to examine their inventory and quarantine the affected product. If customers have affected product, they were to contact Customer Solutions at 1-866-423-2433 to arrange for return of the product to LifeCell. Also, the attached Recall Notification form should have been completed and returned no later than August 17, 2011. Questions should be directed to Customer Solutions at 1-866-423-2433.
Quantity in Commerce 2651 sublots (of 42 lots)
Distribution Nationwide Distribution
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 = FTM and Original Applicant = LIFECELL CORP.
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