Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany. Patient positioner

FDA device recall Z-0247-2016 · posted 2015-11-09 · Terminated

Recall details

Recalling firm

Maquet Cardiovascular Us Sales, Llc

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.

Action taken

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

Status

Terminated

Product code

FWZ

Quantity affected

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

Date initiated

2015-08-17

Date posted

2015-11-09

Date terminated

2016-10-19

Location

Wayne, NJ