FDAClass IIApril 20, 2022

Integra Universal Flexible Arm recall

Integra Universal Flexible Arm part number REF 1362275

Why was Integra Universal Flexible Arm 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI#10381780074670, Lots: AC2109, AC2103, AC2106, AC2110, AC2101, AC2008, AC2009

Product
Integra Universal Flexible Arm part number REF 1362275
Recalling firm
Integra LifeSciences Corp.
Quantity
54
Distribution
US Nationwide Distribution: AL, AZ, FL, GA, IL, MA, MD, NY, OH, OR, PA, TX
Recall date
April 20, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls