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U.S. Department of Health and Human Services

Class 2 Device Recall Joseph Lamelas Atrial Lift System; Atrial Lift System

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  Class 2 Device Recall Joseph Lamelas Atrial Lift System; Atrial Lift System see related information
Date Initiated by Firm March 19, 2014
Date Posted May 02, 2014
Recall Status1 Terminated 3 on August 07, 2014
Recall Number Z-1538-2014
Recall Event ID 68093
Product Classification Instruments, surgical, cardiovascular - Product Code DWS
Product Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery.
Code Information Lot numbers: 166934413 (expires 2016/12/10), and 166903414 (expires 2017/02/03).
Recalling Firm/
Manufacturer		 Biorep Technologies
3225 Nw 112th St
Miami FL 33167-3310
Manufacturer Reason
for Recall		 The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Biorep Technologies sent a letter dated March 19, 2014, to its affected customer. It was advised to due to the high risk, according to our risk categories shown in Table 2, at this time, it is recommended that product be retrieved from its points of use. Any further questions please call (305) 687-8074.
Quantity in Commerce 80 boxes (480 units)
Distribution US Distribution to a distributor in MN.
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.
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