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Terminated

Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was being investigated as a device to determine possible inner ear problems.

FDA Recall Z-2348-2008 · Posted 2008-09-17

Recalling FirmAcacia Engineered Products LLC
Recall StatusTerminated
Product CodeLXV
Date Initiated2008-07-09
Date Terminated2010-02-17
Product Quantity24

Reason for Recall

The firm distributed an unapproved medical device.

Firm Action

On July 9, 2008 the firm issued a Device Recall Notification letter to its consignees by letter on July 9, 2008 by US mail. The recall notification was directed to the end users of the units requesting the return of all units. In the event of a non-responding consignee, the firm will make additional efforts to contact the individual via certified return receipt mail or other form of notification requiring a signature. Follow up direct contact through telephone will also be used. If you have any questions contact Eric Johnson at (615) 202-9370.

Root Cause

PMA

Distribution Pattern

Class II Recall - Nationwide Distribution --- including states of CA, VA, MA and TX.

Official Source

View FDA Recall →

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

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