Z-0248-2016Class II

Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany...

Name: Z-0248-2016 Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany...
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2015-08-17
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2015-08-17 / Terminated

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positioning Elements are... on 2015-08-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0248-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-17
Posted: 2015-11-09
Terminated: 2016-10-19
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: 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.
Product code: FWZ Operating Room Accessories Table Tray
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.
FDA root cause: Under Investigation by 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.
Quantity in commerce: United States (3 sets); Rest of World (47 sets)
Distribution: 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.
Product codes and lots: Part Nos 1007.28A0 (Adjustable Positioning Elements and 1007.24F0 (Universal Frame with Adjustable Positioning Elements)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0248-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0247-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-09
Z-0248-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-09

Product code FWZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)