Device 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.
Z-1538-2014
Product summary
- Event
- Event 68093
- Status
- Terminated
- Classification
- Class II
- Quantity
- 80 boxes (480 units)
- Official record key
device-enforcement:Z-1538-2014
Official wording
Reason: The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.
Code information: Lot numbers: 166934413 (expires 2016/12/10), and 166903414 (expires 2017/02/03).
Distribution pattern: US Distribution to a distributor in MN.
Derived failure modes
-
Unknown
The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.