Z-0906-2022 Class II Ongoing
FDA device recall Z-0906-2022 was initiated by Integra LifeSciences Corp. on Feb 28, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 54.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 20, 2022
- Initiation Date
- Feb 28, 2022
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0906-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026