Reported Apr 20, 2022 · Ongoing

Integra Universal Flexible Arm part number REF 1362275

Integra LifeSciences Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Integra LifeSciences Corp. · 1100 Campus Rd · Princeton, NJ · 08540-6650

Is this the product you have?

  • Integra Universal Flexible Arm part number REF 1362275
Lot codes and dates
  • UDI#10381780074670
  • Lots
    • AC2109
    • AC2103
    • AC2106
    • AC2110
    • AC2101
    • AC2008
    • AC2009
Amount recalled
54

Where it was sold

Why it was recalled

Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.