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U.S. Department of Health and Human Services

Class 2 Device Recall ProLite Mesh

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  Class 2 Device Recall ProLite Mesh see related information
Date Initiated by Firm November 22, 2017
Date Posted February 23, 2018
Recall Status1 Terminated 3 on July 30, 2018
Recall Number Z-0712-2018
Recall Event ID 79293
510(K)Number K151437  
Product Classification Mesh, surgical, polymeric - Product Code FTL
Product ProLite Mesh - mesh, surgical, polymeric

ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.
Code Information Product Code/REF 1010306-06 Lot Number/LOT: 412298
Recalling Firm/
Atrium Medical Corporation
40 Continental Blvd
Merrimack NH 03054-4332
For Additional Information Contact Maryanna Krivak
Manufacturer Reason
for Recall
An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number 412298. ProLite Mesh manufactured as product code 1010306-04 was inadvertently placed inside the pouch of packages labeled with product code 1010306-06 and lot number 412298.
FDA Determined
Cause 2
Under Investigation by firm
Action Please examine inventory to determine if you have any of the affected products listed on page 1. If so, please remove affected products, quarantine them, and place in a secure location. If you have affected product, please contact Getinge Customer Service at internationalcs@atriummed.com for a Return Authorization (RA) and shipping instructions to return any affected product. Pack the product to be returned with the appropriate return documents, and using the shipping instructions provided, arrange for pick up with the designated delivery service provider. Please complete and sign the enclosed Urgent Medical Device Field Safety Notice to acknowledge receipt. Return the completed form to the following e-mail address: MESH2017@getinge.com For further questions, please call (973) 709-7654.
Quantity in Commerce 60 units
Distribution Internationally to Spain only.
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 = FTL and Original Applicant = ATRIUM MEDICAL CORPORATION