—#192647

Product

Integra Universal Flexible Arm part number REF 1362275

FDA product code: FXG — Specula Accessories
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: UDI#10381780074670, Lots: AC2109, AC2103, AC2106, AC2110, AC2101, AC2008, AC2009

Why it was recalled

Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.

Root cause (FDA determination)

Device Design

Action the firm took

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

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

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

Timeline

Recall initiated: 2022-02-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192647. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.