Recall Z-1538-2014
Biorep Technologies · initiated March 19, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot numbers: 166934413 (expires 2016/12/10), and 166903414 (expires 2017/02/03).
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1538-2014
- Initiated
- March 19, 2014
- Posted by FDA
- May 2, 2014
- Terminated
- August 7, 2014
- Product code
- DWS – Instruments, Surgical, Cardiovascular
- Quantity
- 80 boxes (480 units)
- Distribution
- US Distribution to a distributor in MN.
- Recalling firm
- Biorep Technologies, Miami, FL