FDA recall Z-0906-2022

Integra LifeSciences Corp. · Class II · device

Product

Integra Universal Flexible Arm part number REF 1362275

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2022-02-28
Report date
2022-04-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0906-2022