Recall Z-0452-2011 ยท GXQ Dura Substitute
Integra LifeSciences Corp.
DuraGen XS Dural Regeneration Matrix: 4 inches x 5 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.
| Date | Nov 24, 2010 (initiated Sep 29, 2010) |
| Status | Terminated |
| Reason | Test results no longer support a 3 year shelf life. |
| Root cause | Other |
| Action | 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 Se |
| Quantity | 571 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072207 | DURAGEN XS DURAL REGENERATION MATRIX Integra Lifesciences Corp., Aug 23, 2007 |