Integra LifeSciences Corporation

Complete recall history across all FDA and CPSC categories — 29 total recalls

Integra LifeSciences Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (29)

FDA medical device enforcement actions by Integra LifeSciences Corporation

Date Product Reason Class
Mar 11, 2016 Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only ... Integra's post QA release review of historical product release test results f... Class II
Dec 19, 2014 The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. ... Through an investigation of complaints, Integra found that there is the possi... Class II
Mar 28, 2014 Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number... New Deal has identified through a complaint report that some 3.5 mm Diameter ... Class II
May 9, 2013 Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcan... As a result of the investigation into an adverse trend of complaints for repo... Class II
Mar 28, 2013 Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in sur... Due to the process deviation, product lots in question may have been released... Class II
Mar 28, 2013 HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorba... Due to the process deviation, product lots in question may have been released... Class II
Mar 28, 2013 CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorb... Due to the process deviation, product lots in question may have been released... Class II
Mar 28, 2013 Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absor... Due to the process deviation, product lots in question may have been released... Class II
Mar 28, 2013 INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recomm... Due to the process deviation, product lots in question may have been released... Class II
Mar 28, 2013 Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regene... Due to the process deviation, product lots in question may have been released... Class II
Mar 28, 2013 DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matri... Due to the process deviation, product lots in question may have been released... Class II
Mar 28, 2013 OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbab... Due to the process deviation, product lots in question may have been released... Class II
Mar 28, 2013 Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant f... Due to the process deviation, product lots in question may have been released... Class II
Mar 28, 2013 CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorb... Due to the process deviation, product lots in question may have been released... Class II
Mar 28, 2013 Absorbable Collagen Sponge Provided As Intermediate to Another Company Due to the process deviation, product lots in question may have been released... Class II
Mar 28, 2013 NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of perip... Due to the process deviation, product lots in question may have been released... Class II
Mar 28, 2013 Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is... Due to the process deviation, product lots in question may have been released... Class II
Mar 28, 2013 BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane... Due to the process deviation, product lots in question may have been released... Class II
Mar 28, 2013 NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the m... Due to the process deviation, product lots in question may have been released... Class II
Mar 28, 2013 DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix ... Due to the process deviation, product lots in question may have been released... Class II
Mar 28, 2013 OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane i... Due to the process deviation, product lots in question may have been released... Class II
Mar 28, 2013 Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in su... Due to the process deviation, product lots in question may have been released... Class II
Mar 28, 2013 BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable ... Due to the process deviation, product lots in question may have been released... Class II
Mar 28, 2013 HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorba... Due to the process deviation, product lots in question may have been released... Class II
Mar 28, 2013 Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorba... Due to the process deviation, product lots in question may have been released... Class II
Nov 5, 2012 MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The ... An investigation of an adverse trend of complaints conducted by Integra LifeS... Class II
Nov 5, 2012 MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) i... An investigation of an adverse trend of complaints conducted by Integra LifeS... Class II
Aug 9, 2012 Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head R... T-handle screw is used on a complementary product to the CRW, the Integra HRA... Class II
Aug 9, 2012 Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotac... T-handle screw is used on a complementary product to the CRW, the Integra HRA... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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