FDA (Devices) recall action 64778

Integra LifeSciences Corporation recalled 21 products on 2013-05-22

The FDA (Devices) publishes a recall like this one as 21 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 21 pages.

Products: 21
Announced: 2013-05-22
Critical: 0
Units: 550,550

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–21 of 21

HighFDA (Devices)··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.
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.
Category
Distribution
1 state
ModerateFDA (Devices)··2013-05-22
HeliPlug Collagen Wound Dressing Recalled for Pyrogen Levels
Integra LifeSciences is recalling HeliPlug Absorbable Collagen Wound Dressings for dental surgery because process deviations may have resulted in higher pyrogen levels than permitted.
Product
HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical…
Category
Distribution
1 state
ModerateFDA (Devices)··2013-05-22
Integra Recalls CollaPlug Collagen Wound Dressings Due to Pyrogen Levels
Integra LifeSciences is recalling 155,850 boxes of CollaPlug Absorbable Collagen Wound Dressings for dental surgery because process deviations may have resulted in higher levels of pyrogens than permitted.
Product
CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury.…
Category
Distribution
1 state
HighFDA (Devices)··2013-05-22
Integra Recalls Collagen Wound Dressings Due to Pyrogen Levels
Integra LifeSciences is recalling 49,500 boxes of Colla Tape Absorbable Collagen Wound Dressings for dental surgery because process deviations may have resulted in higher levels of pyrogens than permitted.
Product
Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury.…
Category
Distribution
1 state
HighFDA (Devices)··2013-05-22
Integra Absorbable Collagen Sponge Recalled for Pyrogen Levels
Integra LifeSciences is recalling absorbable collagen sponges due to a process deviation that may have resulted in higher pyrogen levels than permitted.
Product
Absorbable Collagen Sponge Provided As Intermediate to Another Company
Category
Distribution
1 state
HighFDA (Devices)··2013-05-22
Integra Recalls INSTAT Hemostatic Agent Due to Pyrogen Levels
Integra LifeSciences is recalling INSTAT absorbable hemostatic agent because process deviations may have resulted in higher pyrogen levels than permitted.
Product
INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or…
Category
Distribution
1 state
HighFDA (Devices)··2013-05-22
Integra NeuraWrap Nerve Protector Recalled for Pyrogen Levels
Integra LifeSciences is recalling 954 boxes of NeuraWrap Nerve Protector because process deviations may have resulted in higher levels of pyrogens than permitted.
Product
NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
Category
Distribution
1 state
HighFDA (Devices)··2013-05-22
Integra Recalls Helitene Absorbable Collagen Hemostatic Sponge
Integra LifeSciences is recalling Helitene Absorbable Collagen Hemostatic Sponge because process deviations may have resulted in higher levels of pyrogens than permitted.
Product
Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Category
Distribution
1 state
ModerateFDA (Devices)··2013-05-22
Integra Recalls DuraGen Dural Graft Matrix Due to Pyrogen Levels
Integra LifeSciences is recalling DuraGen Dural Graft Matrix because process deviations may have resulted in higher levels of pyrogens than permitted.
Product
Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel…
Category
Distribution
1 state
HighFDA (Devices)··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.
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.
Category
Distribution
1 state
HighFDA (Devices)··2013-05-22
Integra Layershield Adhesion Barrier Matrix Recalled for Pyrogen Levels
Integra LifeSciences is recalling 215 boxes of Layershield Adhesion Barrier Matrix because process deviations may have resulted in higher pyrogen levels than permitted.
Product
Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of peridural fibrosis.
Category
Distribution
1 state
HighFDA (Devices)··2013-05-22
Integra Recalls OraMem Absorbable Collagen Membrane Due to Pyrogen Levels
Integra LifeSciences is recalling 812 boxes of OraMem Absorbable Collagen Membrane because process deviations may have resulted in higher levels of pyrogens than permitted.
Product
OraMem Absorbable Collagen Membrane OraMem¿ 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.
Category
Distribution
1 state
ModerateFDA (Devices)··2013-05-22
Integra NeuraGen Nerve Guide Recalled for Pyrogen Deviation
Integra LifeSciences is recalling NeuraGen Nerve Guides because process deviations may have resulted in higher pyrogen levels than permitted.
Product
NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.
Category
Distribution
1 state
HighFDA (Devices)··2013-05-22
Integra Recalls DuraGen XS Dural Regeneration Matrix Due to Pyrogen Levels
Integra LifeSciences is recalling 52 boxes of DuraGen XS Dural Regeneration Matrix because process deviations may have resulted in higher levels of pyrogens than permitted.
Product
DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, porous collagen matrix. DuraGen XS is supplied sterile, non-pyrogenic, for…
Category
Distribution
1 state
HighFDA (Devices)··2013-05-22
Integra OraTape Collagen Wound Dressing Recalled for Pyrogen Levels
Integra LifeSciences is recalling OraTape Absorbable Collagen Wound Dressings because process deviations may have resulted in higher levels of pyrogens than permitted.
Product
OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical…
Category
Distribution
1 state
HighFDA (Devices)··2013-05-22
Integra Ora Plug Collagen Wound Dressing Recalled for Pyrogen Levels
Integra LifeSciences is recalling Ora Plug Absorbable Collagen Wound Dressings due to potential pyrogen levels exceeding specifications.
Product
Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical…
Category
Distribution
1 state
HighFDA (Devices)··2013-05-22
CollaCote Absorbable Collagen Wound Dressing Recalled for Pyrogen Levels
Integra LifeSciences is recalling CollaCote Absorbable Collagen Wound Dressings for dental surgery because process deviations may have resulted in higher levels of pyrogens than permitted.
Product
CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury.…
Category
Distribution
1 state
ModerateFDA (Devices)··2013-05-22
Integra Recalls DuraGen Plus Matrix Due to Pyrogen Levels
Integra LifeSciences is recalling DuraGen Plus Dural Regeneration Matrix because process deviations may have resulted in higher levels of pyrogens than permitted.
Product
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable…
Category
Distribution
1 state
ModerateFDA (Devices)··2013-05-22
Integra Recalls Suturable DuraGen Dural Matrix Due to Pyrogen Levels
Integra LifeSciences is recalling Suturable DuraGen Dural Regenerative Matrix because process deviations may have resulted in higher pyrogen levels than permitted.
Product
Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened…
Category
Distribution
1 state
HighFDA (Devices)··2013-05-22
Integra Recalls Helistat Absorbable Hemostatic Due to Pyrogen Levels
Integra LifeSciences is recalling 24,342 boxes of Helistat Absorbable Hemostatic because process deviations may have resulted in higher levels of pyrogens than permitted.
Product
Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Category
Distribution
1 state
HighFDA (Devices)··2013-05-22
Integra HeliTape Collagen Wound Dressing Recalled for Pyrogen Levels
Integra LifeSciences is recalling HeliTape Absorbable Collagen Wound Dressings for dental surgery due to potential pyrogen levels exceeding specifications.
Product
HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical…
Category
Distribution
1 state