FDA Device recall Z-0031-2014
UNITRAC Pneumatic Retraction Arm
- FDA Device
- Class II
- terminated
- Published 2013-10-30
On 2013-10-30 the FDA classified a Class II recall of UNITRAC Pneumatic Retraction Arm by Aesculap, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0031-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-16 |
| Published | 2013-10-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Aesculap |
| Distribution | US |
Product
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
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.
Identifiers
| code_info | RT040R, all lot numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0031-2014%22
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