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Recall

Class II — Integra LifeSciences Corporation

Recalling firmIntegra LifeSciences Corporation
Registered facilityView this company's 15 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonDue 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.
ProductBioMend® 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.
Quantity20,032 boxes
DistributionWorldwide 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.
Initiated2013-03-28
Classified2013-05-10
Terminated2015-06-03
Recall numberZ-1299-2013
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Integra LifeSciences Corporation (Z-1299-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64778/

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