Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable i...

FDA Device Recall #Z-1284-2013 — Class II — March 28, 2013

Recall Summary

Recall Number Z-1284-2013
Classification Class II — Moderate risk
Date Initiated March 28, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Integra LifeSciences Corporation
Location Plainsboro, NJ
Product Type Devices
Quantity 21,179 boxes

Product Description

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.

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 Pattern

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 Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

Lot / Code Information

1125523, 1125517 1125522, 1125539 1125524, 1125525 1125526, 1125632 1125630, 1125678 1125679 1125677, 1125683 1125628, 1125813 1125814, 1125815 1125629, 1125520 1125521, 1125979 1126031, 1125980 1125981, 1125982 1126030, 1130243 1130071, 1130503 1130379, 1130381 1130384, 1130507 1130374, 1130380 1130382, 1130421 1130505, 1130424 1130654, 1130422 1130423, 1130428 1130639, 1130413 1130414, 1130383 1130425, 1130504 1130506, 1130426 1130427, 1130970 1130827, 1111606 1104879, 1110814 1111610, 1104876 1110815, 1111607 1110268, 1111360 1112339, 1104405 1104877, 1105455 1112008, 1112110 1112111, 1110845 1111940, 1112149 1104880, 1112148 1110244, 1110265 1110846, 1104878 1111609, 1111941 1104881, 1110812, 1110267, 1111359, 1112340, 1105307, 1111611, 1111939, 1112341, 1110266 1112146, 1112147

Other Recalls from Integra LifeSciences Corporation

Recall # Classification Product Date
Z-2777-2016 Class II Integra Meshed Dermal Regeneration Template 5 c... Mar 11, 2016
Z-1084-2015 Class II The MAYFIELD¿ Ultra 360 Base Unit for head posi... Dec 19, 2014
Z-1697-2014 Class II Integra Newdeal SURFIX Fixed Angle Locking Scre... Mar 28, 2014
Z-1736-2013 Class II Integra PANTA Arthrodesis Nail System. Inten... May 9, 2013
Z-1297-2013 Class II Ora Plug Absorbable Collagen Wound Dressing for... Mar 28, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

More from Integra LifeSciences C... Recalls by Firm Recall Reasons Device Safety Stats