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Biorep Technologies recalls Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the
Recalled May 14, 2014 · FDA recall Z-1538-2014 · Biorep Technologies
Hazard
The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component. · FDA Class II
Units
80 boxes (480 units)
Sold at
US Distribution to a distributor in MN.
Description
The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.
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.
Manufacturer(s)
Biorep Technologies
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →