CLASS II Device recall · Reported 22 May 2013 · FDA Enforcement Report

Layershield Adhesion Barrier Matrix Layershield Adhesion recalled

Integra LifeSciences is recalling Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable, distributed nationwide in the US. The recall was initiated on 28 Mar 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1125812 1125816 1126021

Quantity recalled215 boxes

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-1300-2013
FDA event ID: 64778
Recalling firm: Integra LifeSciences, Plainsboro, NJ
Classification: Class II
Status: Terminated
Recall initiated: 28 Mar 2013
FDA classified: 10 May 2013
Reported: 22 May 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Device type: Other Medical Devices

Timeline

28 Mar 2013	Recall initiated by company
10 May 2013	Classified by FDA	+43 days
22 May 2013	Published in enforcement report	+12 days

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

Reason for recall

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Product as listed by the FDA

Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of peridural fibrosis.

Where it was distributed

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

Nationwide Puerto Rico

Questions about this recall

Is Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable recalled?

Yes. Integra LifeSciences recalled Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable on 28 Mar 2013. The recall is Class II and its status is Terminated. Recall number Z-1300-2013.

Why was it recalled?

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Which lots are affected?

1125812 1125816 1126021

Where was it sold?

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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