Synthes recalls Flex Arm components for minimally invasive spine surgery due to potential incompatibility with retractors and adaptors. Affected units have specific lot numbers.
Quick connect feature of instruments may be unable to connect to the male features of Flex Arm Adaptors, Insight Retractors, or other mating parts.
Synthes is recalling Flex Arm components used in minimally invasive spine surgery because their quick connect feature might not properly attach to certain retractors and adaptors. This could lead to improper connections during surgery.
The quick connect feature may not securely attach to male features of Flex Arm Adaptors or other mating parts. This could cause improper connections during minimally invasive spine surgery procedures.
Surgical teams using Synthes Minimally Invasive Support System components for spine procedures. The risk is low as this is a compatibility issue during surgery, not a safety hazard.
Check for lot numbers: 9833185, 9866629, 9888308, 9914323, 9940637, 9982802, H044106, H072780, H144265, H212060, H260544, H260547, H305886, H347867, H430221, H430230.
Identify if your Flex Arm has one of the listed lot numbers: 9833185, 9866629, 9888308, 9914323, 9940637, 9982802, H044106, H072780, H144265, H212060, H260544, H260547, H305886, H347867, H430221, H430230.
The Flex Arm is a component of Synthes Minimally Invasive Support System for secure table mounting during minimally invasive spine surgery.
The quick connect feature may not properly attach to male features of Flex Arm Adaptors or other mating parts, potentially causing improper connections during surgery.
Check the lot number on your Flex Arm; affected units have specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-1511-2018 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-1511-2018 from Synthes. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
