Synthes, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1511-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 5, 2018

Date Posted: May 2, 2018

Recall Number: Z-1511-2018

Event ID: 79763

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.

Status: Terminated

Product Quantity: 84

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

Voluntary or Mandated:

Voluntary: Firm initiated