RecallDepth

Integra Universal Flexible Arm part number REF 1362275

Company
Integra Lifesciences Corp.
Recall Initiated
February 28, 2022
Recall Number
Z-0906-2022
Quantity
54
Firm Location
Princeton, NJ

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

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