Recall Z-1538-2014 ยท DWS Instruments, Surgical, Cardiovascular
Biorep Technologies
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.
| Date | May 2, 2014 (initiated Mar 19, 2014) |
| Status | Terminated |
| Reason | The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component. |
| Root cause | Nonconforming Material/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. |
| Quantity | 80 boxes (480 units) |
| Distribution | US Distribution to a distributor in MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.