Medical Device Recall: Z-0031-2014

FDA Recalls dataset · Firm: Aesculap, Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2013-07-16 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0031-2014.

Recall Res Number
Z-0031-2014
Recalling Firm / Manufacturer
Aesculap, Inc.
FEI Number
2916714
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2013-07-16
Date Posted
2013-10-21
Date Terminated
2014-08-26
Product Code
GAD
Event Number
65952
Product Quantity
217
Product Description UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
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 Details 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.
Distribution Pattern Nationwide Distribution.
Code Information / Serial Numbers RT040R, all lot numbers

Related Establishments / Registrations

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