FDA Recall
Terminated
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.
Recall: Z-1538-2014
·
Initiated March 19, 2014
Recall
- Recall Number
- Z-1538-2014
- Event Number
- 68093
- Firm
- Biorep Technologies
- FEI Number
- 3005593675
- Product Code
- DWS
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- March 19, 2014
- Posted
- May 2, 2014
- Terminated
- August 7, 2014
- Address
- 3225 Nw 112th St, Miami, FL, 33167-3310
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
The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.
Action
Biorep Technologies sent a letter dated March 19, 2014, to its affected customer. It was advised to due to the high risk, according to our risk categories shown in Table 2, at this time, it is recommended that product be retrieved from its points of use. Any further questions please call (305) 687-8074.
Distribution
US Distribution to a distributor in MN.
Quantity
80 boxes (480 units)