—#87963

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.

FDA product code: GXQ — Dura Substitute
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K043427
Affected lot / code info: Catalog Number DURS3391; Lot number 1091575

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp
Address: 105 Morgan Ln, Plainsboro, New Jersey 08536-3339

Distribution

Distribution pattern: Nationwide distribution:Ca, NY, TX, CO, VA, SC, IA, MO, IL, LA, OR, OH, WI, FL, DC, DE, MD, MN.

Timeline

Recall initiated: 2010-01-13
Posted by FDA: 2010-03-11
Terminated: 2010-03-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #87963. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.