Food, drugs, devices › Integra LifeSciences Corporation
Device recall: Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is a
FDA enforcement event 64778 is a device recall by Integra LifeSciences Corporation of Plainsboro, NJ, initiated 28 Mar 2013 and classified Class II, with 21 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 3 Jun 2015. Initiation: voluntary: firm initiated. Integra LifeSciences Corporation has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Integra LifeSciences Corporation, Plainsboro, NJ.
Reason for recall
"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."
Distribution
"Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1282-2013 | 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.. | 15,607 boxes | Class II | Terminated | 22 May 2013 |
| 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, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component. Suturable DuraGen is… | 4, 799 boxes | Class II | Terminated | 22 May 2013 |
| Z-1284-2013 | 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.… | 21,179 boxes | Class II | Terminated | 22 May 2013 |
| Z-1285-2013 | 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… | 52 boxes | Class II | Terminated | 22 May 2013 |
| 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. | 954 boxes | Class II | Terminated | 22 May 2013 |
| 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. | 1,661 boxes | Class II | Terminated | 22 May 2013 |
| 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 control of bleeding by ligature or conventional procedures is ineffective or impractical. | 17, 616 boxes | Class II | Terminated | 22 May 2013 |
| 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 by ligature or conventional procedures is ineffective or impractical. | 24,342 boxes | Class II | Terminated | 22 May 2013 |
| 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 by ligature or conventional procedures is ineffective or impractical. | 14, 525 boxes | Class II | Terminated | 22 May 2013 |
| Z-1291-2013 | 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. Topical administration of the Absorbable… | 49,500 boxes | Class II | Terminated | 22 May 2013 |
| Z-1292-2013 | 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 administration of the Absorbable… | 32,790 boxes | Class II | Terminated | 22 May 2013 |
| Z-1293-2013 | 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 administration of the Absorbable… | 155,850 boxes | Class II | Terminated | 22 May 2013 |
| Z-1294-2013 | 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 administration of the Absorbable Collagen… | 19,030 boxes | Class II | Terminated | 22 May 2013 |
| Z-1295-2013 | 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 administration of the Absorbable Collagen… | 42,570 boxes | Class II | Terminated | 22 May 2013 |
| 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 blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen… | 17,110 boxes | Class II | Terminated | 22 May 2013 |
| 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 blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen… | 31,940 boxes | Class II | Terminated | 22 May 2013 |
| 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 enhance regeneration of the periodontal apparatus. | 812 boxes | Class II | Terminated | 22 May 2013 |
| Z-1299-2013 | 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. | 20,032 boxes | Class II | Terminated | 22 May 2013 |
| 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. | 215 boxes | Class II | Terminated | 22 May 2013 |
| Z-1301-2013 | 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. | 32,446 boxes | Class II | Terminated | 22 May 2013 |
| Z-1302-2013 | Absorbable Collagen Sponge Provided As Intermediate to Another Company | 84,460 boxes | Class II | Terminated | 22 May 2013 |
Context
Other enforcement events for Integra LifeSciences Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 11 Mar 2016 | Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal Regeneration Template | Device | Class II | 1 |
| 19 Dec 2014 | The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ab | Device | Class II | 1 |
| 28 Mar 2014 | Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number | Device | Class II | 1 |
| 9 May 2013 | Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the | Device | Class II | 1 |
| 5 Nov 2012 | MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Mo | Device | Class II | 2 |
| 9 Aug 2012 | Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW | Device | Class II | 2 |
All 7 events for Integra LifeSciences Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 Jun 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.