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Terminated

UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

FDA Recall Z-0031-2014 · Posted 2013-10-21

Recalling FirmAesculap, Inc.
Recall StatusTerminated
Product CodeGAD
Date Initiated2013-07-16
Date Terminated2014-08-26
Product Quantity217

Reason for Recall

Changes were implemented to the UNITRAC instructions for use to ensure safe use and potentially extend the life of the product. This included recommending the use of Sterile Cover JG901 and new Quick Release Coupling RT02OR to eliminate the need to sterilize the UNITRAC and a functional check was added prior to use to ensure optimal functionality of the UNITRAC system.

Firm Action

A letter dated July 16, 2013 was sent requesting users to review the new instructions for use in their entirety, sign the attached Hospital Acknowledgment form and return to Aesculap. An Aesculap representative would be in contact to provide an in-service regarding the process for set-up of the Sterile Cover and required Functional Check. Discontinuation of use and repair of the device was recommended if the joints did not move freely or if the set position drifts during the Functional Check.

Root Cause

Process change control

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

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

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