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Terminated

F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,

FDA Recall Z-1262-2018 · Posted None

Recalling FirmAllen Medical Systems
Recall StatusTerminated
Product CodeN/A
Date Initiated2018-02-21
Date Terminated2020-04-06
Product Quantity83

Reason for Recall

The recalling firm has become aware that the rail section clamps used to attach the leg support of the device may fail during use, which could result in critical harm to the patient.

Firm Action

On February 2, 2018, the firm issued an Urgent Medical Device Correction notification to their distributors to make them aware of the device correction. The firm requested that distributors further disseminate an attached recall letter to consignees. The communication addressed to consignees advised of the issue affecting the device. Consignees were asked to inform users that the device is for armboard use only, and not to be used with the product system's leg support. The notice informed consignees that the firm would provide new units upon completion of development along with revised Instructions for Use. Customers with questions concerning this Urgent Medical Device Correction were referred to Allen Medical Customer Service: (800) 433-5774, 8:30AM-5PM (EST)

Root Cause

Error in labeling

Distribution Pattern

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, France, Saudi Arabia, Germany, and France.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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