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U.S. Department of Health and Human Services

Class 3 Device Recall Strattice Reconstructuve Tissue Matrix for Stoma Reinforcement

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  Class 3 Device Recall Strattice Reconstructuve Tissue Matrix for Stoma Reinforcement see related information
Date Initiated by Firm July 12, 2010
Date Posting Updated September 29, 2010
Recall Status1 Terminated 3 on October 01, 2010
Recall Number Z-2623-2010
Recall Event ID 56261
510(K)Number K070560  
Product Classification Mesh, surgical - Product Code FTM
Product Strattice Reconstructive Tissue Matrix for Stoma Reinforcement.
8 cm x 8 cm
Packaged in an inner foil pouch inside outer foil pouch tertiary carton.
LifeCell Corporation, One Millennium Way, Branchburg, NJ 08876
Strattice is intended for use as a foil tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is used for repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. It is intended for single patient one time use.
Code Information Lot S10624, Exp. 2011-04.
Recalling Firm/
Manufacturer
LifeCell Corporation
1 Millennium Way
Somerville NJ 08876-3876
For Additional Information Contact Bonnie Samuel
908-947-1042
Manufacturer Reason
for Recall
Mislabeled -One lot of product labeled as 8 cm x 8 cm were actually cut using a 6 cm x 6 cm template.
FDA Determined
Cause 2
Employee error
Action LifeCell issued Recall Notice letters dated July 12, 2010 to customers, identifying the affected product, the labeling issue, and actions to be taken by the customer. Two versions of the recall notification were sent, one for implanted units and one for those not yet implanted. Both letters stated that the mislabeling has no impact of the safety or effectiveness of the medical device. Replacement units were offered for all affected units. Those with unused units were to contact LifeCell Customer Solutions for return and replacement of the unit at 1-866-423-2433. Those with implanted units may contact LifeCell Customer Solutions at 1-866-423-2433 with any additional questions or concerns.
Quantity in Commerce 32 units
Distribution Nationwide Distribution: USA, including the states of AZ, DC, FL, GA, ID, IL, KY, LA, MO, NC, OH, OK, OR, TX, WA, and WI.
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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