Integra Lifesciences Corporation

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Holder, Head, Neurosurgical (Skull Clamp)HBL437
• Dura SubstituteGXQ163
• Device, Dermal ReplacementMDD132
• Shunt, Central Nervous System And ComponentsJXG105
• DermatomeGFD95
• Wound Dressing With Animal-Derived Material(S)KGN58
• Dressing, Wound, DrugFRO41
• Sealant, DuralNQR41
• Cuff, NerveJXI25
• Expander, Surgical, Skin GraftFZW17

Recent recalls

• 2015-02-10TerminatedNonconforming Material/Component

  The MAYFIELD Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be used during diagnostic examinations or surgical procedures where a rigid support between the surgical table and a headrest or skull clamp is necessary and positional freedom is required.

  Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use.

• 2014-06-02TerminatedPackage design/selection

  Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various sizes and shapes of bone fixation plates when treating bone fractures or reconstruction of the ankle, foot or hand.

  New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfix screws in Lot no. F626 (Catalogue No. 285322S) have been packaged and labeled as 3.5mm Diameter x 30 mm Length Surfix screws (Catalogue No. 285330S).

• 2013-07-16TerminatedDevice Design

  Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.

  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.

• 2013-05-10TerminatedProcess control

  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 packages in a variety of sizes..

  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.

• 2013-05-10TerminatedProcess control

  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 collagen component. Suturable DuraGen is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes. Suturable DuraGen may be applied using either on-lay or suturing techniques depending on clinical need and surgeon preference.

  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.

• 2013-05-10TerminatedProcess control

  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, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.

  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.

• 2013-05-10TerminatedProcess control

  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 single use in double peel packages in a variety of sizes.

  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.

• 2013-05-10TerminatedProcess control

  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.

  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.

• 2013-05-10TerminatedProcess control

  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.

  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.

• 2013-05-10TerminatedProcess control

  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 impractical.

  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.