Suturable DuraGen Dural Regeneration Matrix; Non-Pyrogenic; Sterility guaranteed unless package is damaged or opened. Rx
FDA device recall Z-1081-2010 · posted 2010-03-11 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GXQ
- Quantity affected
- 94
- Distribution
- Nationwide distribution:Ca, NY, TX, CO, VA, SC, IA, MO, IL, LA, OR, OH, WI, FL, DC, DE, MD, MN.
- Date initiated
- 2010-01-13
- Date posted
- 2010-03-11
- Date terminated
- 2010-03-18
- Location
- Plainsboro, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DURAGEN II DURAL REGENERATION MATRIX (K043427) | Integra Lifesciences Corp. | 2005-01-12 |