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Terminated

Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after surgical interventions as well as for examination and treatment. With a patient in the prone position, the adjustable positioning elements stabilize the upper body while simultaneously relieving the abdominal region in the vertical position with regard to the spine and the large blood vessels there. This positioning method is thus suitable for interventions on the spine with dorsal access to prevent positioning-specific compression with resulting bleeding tenancies. They are made up of the following components: (2) chest and (2) hip elements with padding which are secured in a fixed arrangement to the frames and can be adjusted in all directions independently of each other.

FDA Recall Z-0248-2016 · Posted 2015-11-09

Recalling FirmMaquet Cardiovascular Us Sales, Llc
Recall StatusTerminated
Product CodeFWZ
Date Initiated2015-08-17
Date Terminated2016-10-19
Product QuantityUnited States (3 sets); Rest of World (47 sets)

Reason for Recall

Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number 1007.28A0) in conjunction with Universal Frame (Part Number 1007.24F0) for lumbar spine surgery. The hip elements may have a negative effect on patients- venous backflow under certain conditions and may have been a contributing factor to thromboembolic events.

Firm Action

MAQUET sent an "Urgent Product Recall Medical Device Removal" notice and "Medical Device Removal Response Form" dated August 17, 2015 via UPS to affected customers. The notification identified the issue and the affected product. The notification instructed customers to read the notification and disseminate the information provided to all the users of the device; examine their inventory to determine if they have the Adjustable Positioning Elements; if so, remove the affected products, quarantine them and keep them in a secure location for shipment back to Maquet; and fill out and sign the accompany response form and send via email or fax to Maquet. If the customers have any questions regarding this field action, they were instructed to please contact their local MAQUET Representative or call MAQUET Customer Service at 1-888-627-8383 (Press option 2, then followed by option 3) Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. EDT.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution - US including AL, CA, MO and Internationally to Australia, Brazil, Canada, China, Croatia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Russia, Singapore, South Africa and United Arab Emirates.

Official Source

View FDA Recall →

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

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