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

FDA device recall Z-0031-2014 · posted 2013-10-21 · Terminated

Recall details

Recalling firm

Aesculap, Inc.

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.

Action taken

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

Status

Terminated

Product code

GAD

Quantity affected

217

Distribution

Nationwide Distribution.

Date initiated

2013-07-16

Date posted

2013-10-21

Date terminated

2014-08-26

Location

Center Valley, PA