FDA-Device2022-04-20Class II
Integra Universal Flexible Arm part number REF 1362275
Integra LifeSciences Corp.
Hazard
Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.
Sold states
US Nationwide Distribution: AL, AZ, FL, GA, IL, MA, MD, NY, OH, OR, PA, TX
Affected count
54
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Products
Integra Universal Flexible Arm part number REF 1362275
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0906-2022Don't want to check this manually?
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