Device product
Integra Universal Flexible Arm part number REF 1362275
Z-0906-2022
Product summary
- 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
Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.