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Integra LifeSciences Recalls
246 recalls on record · June 20, 2012 to March 12, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
July 24, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to
Hazard: As a result of the investigation into an adverse trend of complaints for reports of misalignment of the calcaneal or tibial screws during use of the Panta Nail Support Device, Integra has decided to issue this voluntary medical device correction. The misalignment can result in the inability to properly insert the screws into the Panta Nail and create the potential need for revision surgery.
July 17, 2013Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 1
Hazard: The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.
July 3, 2013Medical DevicesFDA
Integra LifeSciences Corp. recalls CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cas
Hazard: As a result of a quality review, labelling content discrepancies were identified between the Instruction for Use (IFU) distributed in the US with the Ascension CMC and the content that is cleared by FDA.
May 22, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls Absorbable Collagen Sponge Provided As Intermediate to Another Company
Hazard: 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.
May 22, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an absorbable, implantable material tha
Hazard: 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.
May 22, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesi
Hazard: 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.
May 22, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable Collagen Membrane is an absorbable, implant
Hazard: 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.
May 22, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane is an absorbable, implantable material that
Hazard: 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.
May 22, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Sur
Hazard: 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.
May 22, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surg
Hazard: 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.
May 22, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Sur
Hazard: 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.
May 22, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Sur
Hazard: 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.
May 22, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Su
Hazard: 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.
May 22, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Su
Hazard: 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.
May 22, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental S
Hazard: 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.
May 22, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmologi
Hazard: 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.
May 22, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than ophthalmologic
Hazard: 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.
May 22, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other
Hazard: 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.
May 22, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closu
Hazard: 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.
May 22, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in w
Hazard: 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.
May 22, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dura
Hazard: 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.
May 22, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and r
Hazard: 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.
May 22, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for
Hazard: 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.
May 22, 2013Medical DevicesFDA
Integra LifeSciences Corporation recalls Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix
Hazard: 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.
April 24, 2013Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. In
Hazard: Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occurs if a beam plan is transmitted from XKnife using DICOM-RT.
March 20, 2013Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel
Hazard: There is a potential for erosion of the CUSA EXcel tip used with the Nosecone. Specifically, the potential for tip erosion occurs when using a CUSA CEM Nosecone if the side of the tip, rather than the annulus of the tip, is in contact with the tissue. This erosion can potentially lead to tip breakage. There were no reports of a patient injury associated with these complaints.
March 6, 2013Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid en
Hazard: Addendum to the Instructions for Use. The addendum emphasizes the warnings and precautions already contained in the device's IFU and also provides additional warnings and precautions that are applicable to the use of electrosurgical equipment in health care facility environments.
February 27, 2013Medical DevicesFDA
Integra LifeSciences Corp. recalls MAYFIELD¿ Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar
Hazard: Integra determined there is a possibility that the Base Units may break during use.
December 26, 2012Medical DevicesFDA
Integra LifeSciences Corporation recalls MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated
Hazard: An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm's Mayfield Composite Series Base Units and Mayfield Skull Clamps. In order to prevent additional complaint reports, the firm decided to recall and replace certain lot codes of the Base Units and Skull Clamps that were d
December 26, 2012Medical DevicesFDA
Integra LifeSciences Corporation recalls MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, M
Hazard: An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm's Mayfield Composite Series Base Units and Mayfield Skull Clamps. In order to prevent additional complaint reports, the firm decided to recall and replace certain lot codes of the Base Units and Skull Clamps that were d