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Terminated

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.

FDA Recall Z-1538-2014 · Posted 2014-05-02

Recalling FirmBiorep Technologies
Recall StatusTerminated
Product CodeDWS
Date Initiated2014-03-19
Date Terminated2014-08-07
Product Quantity80 boxes (480 units)

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Distribution to a distributor in MN.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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