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

BioMend Absorbable Collagen Membrane BioMend¿ Absorbable recalled

Integra LifeSciences is recalling BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an, 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 codes1105251, 1105462, 1110805, 1110806, 1111144, 1110480, 1111145, 1111358, 1105392, 1110142, 1110807, 1111146, 1111362, 1111640, 1105252, 1105463, 1110808, 1111147, 1111865, 1110671, 1110672, 1111958, 1105393, 1111959, 1105394, 1110480, 1112022, 1105391

Quantity recalled32,446 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-1301-2013
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

BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.

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

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?

1105251, 1105462, 1110805, 1110806, 1111144, 1110480, 1111145, 1111358, 1105392, 1110142, 1110807, 1111146, 1111362, 1111640, 1105252, 1105463, 1110808, 1111147, 1111865, 1110671, 1110672, 1111958, 1105393, 1111959, 1105394, 1110480, 1112022, 1105391

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.

Other products in this recall event

20 other products · FDA event 64778

This product is part of a recall event; the main page for the event is Ora Plug Absorbable Collagen Wound Dressing recalled.

Reported	Class	Recall	Company	Reason	Where
22 May 2013	CLASS II	Ora Plug Absorbable Collagen Wound Dressing recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	HeliTape Absorbable Collagen Wound Dressing recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	Helitene Absorbable Collagen Hemostatic Sponge Helitene recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	OraMem Absorbable Collagen Membrane OraMem¿ Absorbable recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	DuraGen XS Dural Regeneration Matrix DuraGen XS Dural recalled	Integra LifeSciences	Sterility	Nationwide
22 May 2013	CLASS II	NeuraWrap Nerve Protector NeuraWrap Nerve Protector recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	Layershield Adhesion Barrier Matrix Layershield Adhesion recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	Absorbable Collagen Sponge Provided As Intermediate recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	CollaCote Absorbable Collagen Wound Dressing recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	Dural Graft Matrix DuraGen¿ Dural Graft Matrix recalled	Integra LifeSciences	Sterility	Nationwide
22 May 2013	CLASS II	OraTape Absorbable Collagen Wound Dressing recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	DuraGen Plus Dural Regeneration Matrix DuraGen Plus recalled	Integra LifeSciences	Sterility	Nationwide
22 May 2013	CLASS II	Suturable DuraGen Dural Regenerative Matrix Suturable recalled	Integra LifeSciences	Sterility	Nationwide
22 May 2013	CLASS II	Instat - Agent, Absorbable Hemostatic recalled by Integra LifeSciences	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	Colla Tape Absorbable Collagen Wound Dressing recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	CollaPlug Absorbable Collagen Wound Dressing recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	HeliPlug Absorbable Collagen Wound Dressing recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide
22 May 2013	CLASS II	Helistat Absorbable Hemostatic,Collagen Based Helistat recalled	Integra LifeSciences	Manufacturing (CGMP) Deviations	Nationwide

More recalls from Integra LifeSciences

All 246

Reported	Class	Recall	Company	Reason	Where
12 Mar 2025Device	CLASS II	Aurora Surgiscope System, Sterile recalled by Integra LifeSciences	Integra LifeSciences	Device Malfunction	Nationwide
19 Feb 2025Device	CLASS II	MediHoney¿ Gel MediHoney¿ Wound & Burn Dressing Gel recalled	Integra LifeSciences	Packaging Defects	Nationwide
29 Jan 2025Device	CLASS II	Codman Certas Plus Programmable Valve Inline Small Valve Only recalled	Integra LifeSciences	Packaging Defects	Nationwide
29 Jan 2025Device	CLASS II	Codman Certas Plus Programmable Valve Right Angle Valve Only recalled	Integra LifeSciences	Packaging Defects	Nationwide
29 Jan 2025Device	CLASS II	Codman Certas Plus Programmable Valve Inline Small Valve Only recalled	Integra LifeSciences	Packaging Defects	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide