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U.S. Department of Health and Human Services

Class 2 Device Recall UNITRAC Pneumatic Retraction Arm

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  Class 2 Device Recall UNITRAC Pneumatic Retraction Arm see related information
Date Initiated by Firm July 16, 2013
Date Posted October 21, 2013
Recall Status1 Terminated 3 on August 26, 2014
Recall Number Z-0031-2014
Recall Event ID 65952
Product Classification Retractor - Product Code GAD
Product UNITRAC Pneumatic Retraction Arm.

A support arm used to hold surgical instruments during surgical procedures.
Code Information RT040R, all lot numbers
Recalling Firm/
Manufacturer		 Aesculap, Inc.
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact Customer Support
800-258-1946 Ext. 5067
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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