FDA recall Z-0642-2018

Product

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

Reason for recall

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

Distribution

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.

Key facts

Status

Terminated

Initiation date

2017-10-06

Report date

2018-02-28

Termination date

2019-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Acton, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0642-2018