—#94909

Product

DuraGen XS Dural Regeneration Matrix: 3 inches x 3 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of dura matter.

FDA product code: GXQ — Dura Substitute
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K072207
Affected lot / code info: Catalog number DXM1033, Lot number 1073337, 1080615, 1091090, 1092074, 1092192, 1095441, 1101582, 1101990.

Why it was recalled

Test results no longer support a 3 year shelf life.

Root cause (FDA determination)

Other

Action the firm took

Integra LifeSciences Corporation sent an URGENT Product Recall Notification letter dated September 29, 2010, to all affected customers. Integra NeruoSpecialists were informed of the recall via telephone conference call and recall notification letters sent by e-mail. Letters were also sent to customers by Federal Express with copies of e-mail provided to Interga Neuro Specialists on October 1, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately quarantine any affected product and contact Integra Customer Service at 1-800-654-2873, select option 5, followed by option 3. Customers were instructed to fill out and return the enclosed "Recall Acknowledgement and Return Form" indicating whether or not they possessed any of the affected product. For any questions related to this recall call 1-800-654-2873 and selection option 1.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: Nationwide Distribution including AK, AL, AZ, CA, CO, DC, DE, FL, GA, HI, IL, IN, LA, MA, MD, ME, MN, MO, MT, NC, ND, NH, NJ, NM, NY, OK, PA, TN, TX, UT, VA, VT, WA, WI, AND WV.

Timeline

Recall initiated: 2010-09-29
Posted by FDA: 2010-11-24
Terminated: 2012-04-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94909. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.