Date Initiated by Firm | July 02, 2008 |
Date Posted | September 20, 2008 |
Recall Status1 |
Terminated 3 on September 22, 2008 |
Recall Number | Z-2328-2008 |
Recall Event ID |
48964 |
PMA Number | P900033 |
Product Classification |
Device, Dermal Replacement - Product Code MDD
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Product | Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile;
Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 USA |
Code Information |
Catalog Number 38101, Lot Number 105BA0121823 |
Recalling Firm/ Manufacturer |
Integra LifeSciences Corp 105 Morgan Ln Plainsboro NJ 08536-3339
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For Additional Information Contact | Thomas Tarca 609-275-0500 |
Manufacturer Reason for Recall | Product labeled with an expiration date on May 2010, while the actual expiration date should be April 2010. |
FDA Determined Cause 2 | Labeling mix-ups |
Action | The firm issued a letter titled URGENT-RECALL NOTICE to Integra Sales Reps on July 2, 2008.
Contact Integra at 609-799-3297 if you have questions. |
Quantity in Commerce | 10 units |
Distribution | Product was distributed to 5 hospitals in TN, CA, NY, IN and AL. |
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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