FDA recall Z-1511-2018

Product

Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure table mounting for minimally invasive spine surgery. The Flex Arm is designed to hold Synthes Minimally Invasive Retractors, which are connected to the Flex Arm by adapters.

Reason for recall

Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Switzerland and Japan

Key facts

Status

Terminated

Initiation date

2018-03-05

Report date

2018-05-02

Termination date

2019-10-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Chester, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1511-2018