Z-1538-2014 Class II Terminated
FDA device recall Z-1538-2014 was initiated by Biorep Technologies on March 19, 2014 and is designated Class II. 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. The recall status is terminated (terminated August 7, 2014). Affected quantity: 80 boxes (480 units).
Recall Details
- Product Type
- Devices
- Report Date
- May 14, 2014
- Initiation Date
- March 19, 2014
- Termination Date
- August 7, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80 boxes (480 units)
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.
Distribution Pattern
US Distribution to a distributor in MN.
Code Information
Lot numbers: 166934413 (expires 2016/12/10), and 166903414 (expires 2017/02/03).