Z-1081-2010

Suturable DuraGen Dural Regeneration Matrix; Non-Pyrogenic; Sterility guaranteed unless package is damaged or...

Name: Z-1081-2010 Suturable DuraGen Dural Regeneration Matrix; Non-Pyrogenic; Sterility guaranteed unless package is damaged or...
Creator: Integra LifeSciences Corp
Published: 2010-01-13
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2010-01-13 / Terminated

FDA source

Integra LifeSciences Corp began a recall of Suturable DuraGen Dural Regeneration Matrix; Non-Pyrogenic; Sterility guaranteed unless package is damaged or opened. Rx only. Manufacturer: Integra... on 2010-01-13. The reason FDA records is "One lot of Suturable DuraGen Dural Regeneration Matrix (# 1091575) did not pass stability testing at certain time points for Suture Retention Strength and Shrink Temperature specifications". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1081-2010
Status: Terminated
Initiated: 2010-01-13
Posted: 2010-03-11
Terminated: 2010-03-18
Recalling firm: Integra LifeSciences Corporation
Product: Suturable DuraGen Dural Regeneration Matrix; Non-Pyrogenic; Sterility guaranteed unless package is damaged or opened. Rx only. Manufacturer: Integra LifeSciences Corporation, Plainsboro, NJ 08536 Suturable DuraGen is an absorbable implant for repair of dural defects. It is indicated as a dural substitute for the repair of dura matter.
Product code: GXQ Dura Substitute
Reason for recall: One lot of Suturable DuraGen Dural Regeneration Matrix (# 1091575) did not pass stability testing at certain time points for Suture Retention Strength and Shrink Temperature specifications.
FDA root cause: Other
Action: An "URGENT PRODUCT RECALL NOTIFICATION" dated January 13, 2010, was sent via Federal Express to customers. The notification described the product, problem, hazard involved and action to be taken by customers. In the event that the customers have in their possession any products from the specific lot number 1091576, the customers are being ask to please immediately quarantine all stock on hand and contact their local Integra Sales representative for further assistance and for arrangements of product return. The customers are being ask to return the enclosed "Recall Acknowledge and Return Form" indicating whether or not they possess any of the affected product identified. Integra will replace any product affected by this Recall that is returned. Please feel free to contact me at 609-936-5407 should you have any additional questions.
Quantity in commerce: 94
Distribution: Nationwide distribution:Ca, NY, TX, CO, VA, SC, IA, MO, IL, LA, OR, OH, WI, FL, DC, DE, MD, MN.
Product codes and lots: Catalog Number DURS3391; Lot number 1091575

Product code GXQ

K043427Class IIDuragen II Dural Regeneration MatrixIntegra Lifesciences Corp. / cleared 2005-01-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)