The Recall Desk

Manufacturer

Integra LifeSciences Corporation

29 recalls in our database name Integra LifeSciences Corporation as the manufacturing or recalling firm.

What the numbers show

Total
29
Critical
0
Severe
0
Most recent
2016-09-21

Of the 29 recalls from Integra LifeSciences Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 29

  • ModerateFDA (Devices)·Z-2777-2016·2016-09-21

    Integra Meshed Dermal Regeneration Template Recalled for Calculation Error

    Integra LifeSciences is recalling 14 packages of Meshed Dermal Regeneration Template due to an incorrect calculation of peel strength test results.

    Product
    Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal Regeneration Template, (Integra template) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1084-2015·2015-02-18

    Integra Recalls Mayfield Ultra 360 Base Units Due to Locking Handle Failure

    Integra LifeSciences is recalling 1,053 Mayfield Ultra 360 Base Units because the locking handle mechanism may fail during use, posing a risk to patients.

    Product
    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 u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1697-2014·2014-06-11

    Integra Newdeal SURFIX Screws Recalled for Packaging Labeling Error

    Integra LifeSciences is recalling specific lots of SURFIX locking screws because some 22mm units were mislabeled as 30mm units.

    Product
    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 frac
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1736-2013·2013-07-24

    Integra PANTA Arthrodesis Nail System Recalled for Screw Misalignment

    Integra LifeSciences is recalling PANTA Arthrodesis Nail Systems due to screw misalignment that may require revision surgery.

    Product
    Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1288-2013·2013-05-22

    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 imp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1294-2013·2013-05-22

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1285-2013·2013-05-22

    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 single
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1286-2013·2013-05-22

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1292-2013·2013-05-22

    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. Topical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1296-2013·2013-05-22

    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 a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1301-2013·2013-05-22

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1299-2013·2013-05-22

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1291-2013·2013-05-22

    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. Topica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1297-2013·2013-05-22

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1290-2013·2013-05-22

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1298-2013·2013-05-22

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1300-2013·2013-05-22

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1302-2013·2013-05-22

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1289-2013·2013-05-22

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1293-2013·2013-05-22

    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. Topical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1284-2013·2013-05-22

    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, n
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1287-2013·2013-05-22

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1282-2013·2013-05-22

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1295-2013·2013-05-22

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1283-2013·2013-05-22

    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 colla
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Integra LifeSciences

company in Plainsboro Center, United States

Country
United States
Founded
1989

Official website

Source: Wikidata (Q30283982), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.