Reported May 14, 2014 · Terminated

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

Biorep Technologies

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biorep Technologies · 3225 Nw 112th St · Miami, FL · 33167-3310

Is this the product you have?

  • 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.
Lot codes and dates
  • Lot numbers
    • 166934413 (expires 2016/12/10)
    • and 166903414 (expires 2017/02/03)
Amount recalled
80 boxes (480 units)

Where it was sold

Why it was recalled

The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 7, 2014 · Data as of Sep 19, 5:30 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.