High FDA (Devices)·Z-1299-2013·Announced 2013-05-22

Integra Recalls BioMend Extend Membranes Due to Pyrogen Levels

Integra LifeSciences is recalling BioMend Extend Absorbable Collagen Membranes because process deviations may have resulted in higher levels of pyrogens than permitted.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves pyrogens in an implantable medical device, which poses a risk of harm (fever/adverse reaction) even though specific injuries are not reported in the source text.

Plain-English summary

Integra LifeSciences Corporation is recalling 20,032 boxes of BioMend Extend Absorbable Collagen Membranes. This absorbable, implantable material is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.

The recall was initiated due to a process deviation that may have caused the affected product lots to be released with higher levels of pyrogens than permitted by the product specifications. Pyrogens are substances that can cause fever or other adverse reactions when introduced into the body.

The affected products were distributed worldwide, including the United States (nationwide, including Puerto Rico) and countries such as the Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa. Specific lot codes involved in the recall include 1104846, 1105175, 1105253, 1110810, 1110811, 1111149, 1111859, 1104847, 1105176, 1105254, 1110809, 1111860, 1104848, 1110819, 1110820, 1111148, and 1111861. Healthcare providers and patients should contact their healthcare provider or the manufacturer for further instructions regarding the use or return of these products.

The recalled product

Product: BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" 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.
Manufacturer: Integra LifeSciences Corporation
Category: Medical Device — Dental / Periodontal
Hazard: pyrogen
contamination
Affected units: 20,032

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

1104846
1105175 1105253
1110810 1110811
1111149 1111859
1104847 1105176
1105254 1110809
1111860 1104848
1110819 1110820
1111148 1111861

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 21 recalled by Integra LifeSciences Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 21 products in this recall →

Same manufacturer · Integra LifeSciences Corporation

See all →

Moderate
Integra Meshed Dermal Regeneration Template Recalled for Calculation Error
FDA (Devices) · 2016-09-21
High
Integra Recalls Mayfield Ultra 360 Base Units Due to Locking Handle Failure
FDA (Devices) · 2015-02-18
Moderate
Integra Newdeal SURFIX Screws Recalled for Packaging Labeling Error
FDA (Devices) · 2014-06-11
High
Integra PANTA Arthrodesis Nail System Recalled for Screw Misalignment
FDA (Devices) · 2013-07-24
High
Integra OraTape Collagen Wound Dressing Recalled for Pyrogen Levels
FDA (Devices) · 2013-05-22

Same hazard · pyrogen