Recall Z-1081-2010 ยท GXQ Dura Substitute
Integra LifeSciences Corp
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.
| Date | Mar 11, 2010 (initiated Jan 13, 2010) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 94 |
| Distribution | Nationwide distribution:Ca, NY, TX, CO, VA, SC, IA, MO, IL, LA, OR, OH, WI, FL, DC, DE, MD, MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043427 | DURAGEN II DURAL REGENERATION MATRIX Integra Lifesciences Corp., Jan 12, 2005 |