Z-0906-2022 Class II Ongoing

Recalled by Integra LifeSciences Corp. — Princeton, NJ

Recall Details

Product Type
Devices
Report Date
April 20, 2022
Initiation Date
February 28, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
54

Product Description

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 Pattern

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

Code Information

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