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Recall Observatory FDA recall evidence

Device 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.

Z-1511-2018

March 05, 2018

Class II

Product summary

Firm
Synthes, Inc.
Event
Event 79763
Status
Terminated
Classification
Class II
Quantity
84
Official record key
device-enforcement:Z-1511-2018

Official wording

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

Code information: Lot numbers 9833185, 9866629, 9888308, 9914323, 9940637, 9982802, H044106, H072780, H144265, H212060, H260544, H260547, H305886, H347867, H430221, H430230

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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