CLASS II ONGOING Device recall · Reported 20 Apr 2022 · FDA Enforcement Report

Integra Universal Flexible Arm recalled by Integra LifeSciences

Integra LifeSciences is recalling Integra Universal Flexible Arm, distributed nationwide in the US. The recall was initiated on 28 Feb 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI#10381780074670, Lots: AC2109, AC2103, AC2106, AC2110, AC2101, AC2008, AC2009

Quantity recalled54

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0906-2022
FDA event ID: 89830
Recalling firm: Integra LifeSciences, Princeton, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 28 Feb 2022
FDA classified: 11 Apr 2022
Reported: 20 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

28 Feb 2022	Recall initiated by company
11 Apr 2022	Classified by FDA	+42 days
20 Apr 2022	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Integra Universal Flexible Arm part number REF 1362275

Where it was distributed

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

Nationwide Alabama Arizona Florida Georgia Illinois Massachusetts Maryland New York Ohio Oregon Pennsylvania Texas

Questions about this recall

Is Integra Universal Flexible Arm recalled?

Yes. Integra LifeSciences recalled Integra Universal Flexible Arm on 28 Feb 2022. The recall is Class II and its status is Ongoing. Recall number Z-0906-2022.

Why was it 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.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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