UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
- Company
- Aesculap Inc
- Recall Initiated
- July 16, 2013
- Posted
- October 21, 2013
- Terminated
- August 26, 2014
- Recall Number
- Z-0031-2014
- Quantity
- 217
- Firm Location
- Center Valley, PA
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.
Distribution
Nationwide Distribution.
Lot / Code Info
RT040R, all lot numbers
Root Cause
Process change control
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.