Z-0031-2014Class II

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

Name: Z-0031-2014 UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures
Creator: Aesculap, Inc.
Published: 2013-07-16
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2013-07-16 / Terminated / root cause: labeling and UDI

FDA source

Aesculap, Inc. began a recall of UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures on 2013-07-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0031-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-16
Posted: 2013-10-21
Terminated: 2014-08-26
Recalling firm: Aesculap Inc
Product: UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Product code: GAD Retractor
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.
Root cause tag: labeling and UDI
FDA root cause: Process change control
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.
Quantity in commerce: 217
Distribution: Nationwide Distribution.
Product codes and lots: RT040R, all lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0031-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0031-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-21

Product code GAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)