Synthes, Inc. recalls Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which pro…

Recall date

March 5, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1511-2018

FDA classification

Class II

Brand / firm

Synthes, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.