Recall Z-1538-2014— Biorep Technologies
Class II · Terminated
Class II FDA medical device recall by Biorep Technologies, initiated 2014-03-19, terminated 2014-08-07. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component..
- Recalling firm
- Biorep Technologies
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-19
- Terminated
- 2014-08-07
- Firm location
- Miami, FL, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.