Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0031-2014

July 16, 2013

Class II

Product summary

Firm
Aesculap, Inc.
Event
Event 65952
Status
Terminated
Classification
Class II
Quantity
217
Official record key
device-enforcement:Z-0031-2014

Official wording

Reason: 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.

Code information: RT040R, all lot numbers

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.