Recall Z-0452-2011
Integra LifeSciences Corp. · initiated September 29, 2010
Product
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.
Codes / lots: Catalog number DXM1045, Lot number 1084359, 1091578, 1093431, 1094405, 1095442, 1095784, 1101583, 1101989.
Reason for recall
Test results no longer support a 3 year shelf life.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0452-2011
- Initiated
- September 29, 2010
- Posted by FDA
- November 24, 2010
- Terminated
- April 23, 2012
- Product code
- GXQ – Dura Substitute
- 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.
- Recalling firm
- Integra LifeSciences Corp., Plainsboro, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0450-2011 | DuraGen XS Dural Regeneration Matrix: 2 inches x 2 inches. Non Pyrogenic; Rx…Test results no longer support a 3 year shelf life. | 09/29/2010Terminated |
| Z-0451-2011 | DuraGen XS Dural Regeneration Matrix: 3 inches x 3 inches. Non Pyrogenic; Rx…Test results no longer support a 3 year shelf life. | 09/29/2010Terminated |
| Z-0453-2011 | DuraGen XS Dural Regeneration Matrix: 5 inches x 7 inches. Non Pyrogenic; Rx…Test results no longer support a 3 year shelf life. | 09/29/2010Terminated |
| Z-0454-2011 | DuraGen XS Dural Regeneration Matrix: 1 inch x 3 inches. Non Pyrogenic; Rx only;Integra…Test results no longer support a 3 year shelf life. | 09/29/2010Terminated |