Biorep Technologies: Medical Device Recall in 2014 - (Recall #: Z-1538-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 19, 2014

Date Posted: May 14, 2014

Recall Number: Z-1538-2014

Event ID: 68093

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.

Status: Terminated

Product Quantity: 80 boxes (480 units)

Code Information:

Lot numbers: 166934413 (expires 2016/12/10), and 166903414 (expires 2017/02/03).

Distribution Pattern:

US Distribution to a distributor in MN.

Voluntary or Mandated:

Voluntary: Firm initiated