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Terminated

Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.

FDA Recall Z-0642-2018 · Posted None

Recalling FirmAllen Medical Systems
Recall StatusTerminated
Product CodeJEB
Date Initiated2017-10-06
Date Terminated2019-04-03
Product Quantity161 units total

Reason for Recall

The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.

Firm Action

In October of 2017 an Urgent Medical Device Correction letter was sent to customers notifying them of the recall and requesting customers to immediately remove any frames from use that are in the serial number range subject to the recall and that a service technician will coordinate correction of the device. If the device was sent to another company, to forward the recall notice o that person or firm. If you have any questions concerning this Urgent Medical Device Correction, please contact Allen Medical Customer Service at (800) 433-5774, 8:30 5:00 pm EST.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution. US Nationwide, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Netherlands, Spain, Switzerland, Taiwan, UAE, and UK.

Official Source

View FDA Recall →

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

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