Aesculap, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0031-2014)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2013.
Data Source: FDA.
Product Description:
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Product Classification:
Class II
Date Initiated: July 16, 2013
Date Posted: October 30, 2013
Recall Number: Z-0031-2014
Event ID: 65952
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.
Status: Terminated
Product Quantity: 217
Code Information:
RT040R, all lot numbers
Distribution Pattern:
Nationwide Distribution.
Voluntary or Mandated:
Voluntary: Firm initiated