DuraGen XS Dural Regeneration Matrix: 4 inches x 5 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plai

FDA device recall Z-0452-2011 · posted 2010-11-24 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

Test results no longer support a 3 year shelf life.

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.

Root cause

Other

Status

Terminated

Product code

GXQ

Quantity affected

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.

Date initiated

2010-09-29

Date posted

2010-11-24

Date terminated

2012-04-23

Location

Plainsboro, NJ

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