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Synthes, Inc. recalls Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which
Recalled May 2, 2018 · FDA recall Z-1511-2018 · Synthes
Hazard
Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts. · FDA Class II
Units
84
Sold at
Worldwide distribution - US Nationwide and the countries of Canada, Switzerland and Japan
Description
Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts.
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.
Manufacturer(s)
Synthes, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →