Integra Universal Flexible Arm part number REF 1362275
This recall is currently active, issued February 28, 2022. It was issued by Integra Lifesciences Corp..
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- February 28, 2022
- Recall Number
- Z-0906-2022
- Quantity
- 54
- Firm Location
- Princeton, NJ
- Official Source
- View on FDA website ↗
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
Lot / Code Info
UDI#10381780074670, Lots: AC2109, AC2103, AC2106, AC2110, AC2101, AC2008, AC2009
Root Cause
Device Design
Action Taken
Urgent Voluntary Medical Device Recall Notice dated 02/28/2022 was sent via FexEx. Customers are instructed to remove the affected product from service, return it to Integra and complete and submit the attached acknowledgment form. Contact Customer Service with questions: Phone: 1-800-654-2873, Email: custsvcnj@integralife.com