Z-1538-2014Class II

Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for...

Name: Z-1538-2014 Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for...
Creator: Biorep Technologies
Published: 2014-03-19
License: https://open.fda.gov/license/

Biorep Technologies, Inc. / initiated 2014-03-19 / Terminated / root cause: manufacturing process

FDA source

Biorep Technologies began a recall of 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 on 2014-03-19. FDA classified it as Class II and gives the reason as "The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1538-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-19
Posted: 2014-05-02
Terminated: 2014-08-07
Recalling firm: Biorep Technologies, Inc.
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.
Product code: DWS Instruments, Surgical, Cardiovascular
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 80 boxes (480 units)
Distribution: US Distribution to a distributor in MN.
Product codes and lots: Lot numbers: 166934413 (expires 2016/12/10), and 166903414 (expires 2017/02/03).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1538-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1538-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-02

Product code DWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)