The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1301-2013·Announced 2013-05-22

Integra Recalls BioMend Membranes Due to Pyrogen Levels

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

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 involves a medical device with a potential safety hazard (pyrogens) where no specific injuries or illnesses are reported in the source text, fitting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Integra LifeSciences Corporation is recalling 32,446 boxes of BioMend Absorbable Collagen Membranes. The product is an absorbable, implantable material 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.

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 are listed in the agency's recall record.

The recalled product

Product
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.
Manufacturer
Integra LifeSciences Corporation
Category
Medical Device — Dental / Periodontal
Hazard
Affected units
32,446

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 (20)

  • 1105251
  • 1105462
  • 1110805
  • 1110806
  • 1111144
  • 1110480
  • 1111145
  • 1111358
  • 1105392
  • 1110142
  • 1110807
  • 1111146
  • 1111362
  • 1111640
  • 1105252
  • 1105463
  • 1110808
  • 1111147
  • 1111865
  • 1110671

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 →

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