FDAClass IIMay 14, 2014

Joseph Lamelas Atrial Lift System recall

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…

Why was Joseph Lamelas Atrial Lift System recalled?

The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot numbers: 166934413 (expires 2016/12/10), and 166903414 (expires 2017/02/03).

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…
Recalling firm
Biorep Technologies
Quantity
80 boxes (480 units)
Distribution
US Distribution to a distributor in MN.
Recall date
May 14, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls