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Open, Classified

Integra Universal Flexible Arm part number REF 1362275

FDA Recall Z-0906-2022 · Posted None

Recalling FirmIntegra LifeSciences Corp.
Recall StatusOpen, Classified
Product CodeFXG
Date Initiated2022-02-28
Product Quantity54

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.

Firm Action

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: [email protected]

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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