Skip to content
Recall Observatory FDA recall evidence

Device product

Integra Universal Flexible Arm part number REF 1362275

Z-0906-2022

February 28, 2022

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 89830
Status
Ongoing
Classification
Class II
Quantity
54
Official record key
device-enforcement:Z-0906-2022

Official wording

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

Code information: UDI#10381780074670, Lots: AC2109, AC2103, AC2106, AC2110, AC2101, AC2008, AC2009

Distribution pattern: US Nationwide Distribution: AL, AZ, FL, GA, IL, MA, MD, NY, OH, OR, PA, TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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