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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-1283-2013 - 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, pl...
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2
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05/10/2013
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FEI # 1121308 Integra LifeSciences Corporation
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Z-1296-2013 - 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 blo...
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2
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05/10/2013
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FEI # 1121308 Integra LifeSciences Corporation
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Z-1298-2013 - 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...
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2
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05/10/2013
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FEI # 1121308 Integra LifeSciences Corporation
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Z-1297-2013 - 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 bl...
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2
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05/10/2013
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FEI # 1121308 Integra LifeSciences Corporation
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Z-1286-2013 - 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.
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2
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05/10/2013
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FEI # 1121308 Integra LifeSciences Corporation
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Z-1287-2013 - 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.
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2
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05/10/2013
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FEI # 1121308 Integra LifeSciences Corporation
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Z-1300-2013 - Layershield Adhesion Barrier Matrix
Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of peridural fibrosis.
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2
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05/10/2013
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FEI # 1121308 Integra LifeSciences Corporation
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Z-1288-2013 - 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 ...
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2
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05/10/2013
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FEI # 1121308 Integra LifeSciences Corporation
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Z-1290-2013 - 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...
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2
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05/10/2013
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FEI # 1121308 Integra LifeSciences Corporation
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Z-1289-2013 - 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 ...
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2
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05/10/2013
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FEI # 1121308 Integra LifeSciences Corporation
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