Date Initiated by Firm | January 16, 2009 |
Date Posted | March 06, 2009 |
Recall Status1 |
Terminated 3 on June 25, 2009 |
Recall Number | Z-1035-2009 |
Recall Event ID |
50899 |
PMA Number | P900033 |
Product Classification |
Dermal Replacement Device - Product Code MDD
|
Product | Integra Dermal Regeneration Template-TS
Catalog number 32021
Catalog number 82021 |
Code Information |
Lot Numbers: 105BA0134826 and 105BB0134826. Lot Numbers: 105BY0134826 and 105BW0134826. |
Recalling Firm/ Manufacturer |
Integra LifeSciences Corp 105 Morgan Ln Plainsboro NJ 08536-3339
|
For Additional Information Contact | Juith O'Grady 609-936-2375 |
Manufacturer Reason for Recall | Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained. |
FDA Determined Cause 2 | Pending |
Action | Urgent: Product Recall Notification letters were sent on January 21, 1009 via Federal Express. The letter asked customers to immediately quarantine any stock on hand and contact their local Integra Sales Representative for further assistance and arrangement of product returns. The enclosed "Recall Acknowledgement and Return Form" indicating whether or not customers possess any of the affected product should also be completed and returned. Company is conducting recall to the hospital level. Questions should be directed to Judy O'Grady at 609-936-2317. |
Quantity in Commerce | 31 units |
Distribution | Nationwide Distribution -- including states of FL, CA, GA, FL, CT, MT, IL, TX, WA, TN, NC, IN, AZ, MD, CO, MO, and TN. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database | PMAs with Product Code = MDD
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