Date Initiated by Firm |
May 02, 2003 |
Date Posted |
June 04, 2003 |
Recall Status1 |
Terminated 3 on November 03, 2003 |
Recall Number |
Z-0904-03 |
Recall Event ID |
26327 |
PMA Number |
P000036 |
Product Classification |
Dressing, Wound And Burn, Interactive - Product Code MGR
|
Product |
Dermagraft, Human Fibroblast -Derived Dermal Substitute, 2 in. by 3 in.. |
Code Information |
Lot 116098 |
Recalling Firm/ Manufacturer |
Smith and Nephew Wound Management (La Jolla) 10933 N Torrey Pines Road Ste 200 San Diego CA 92037
|
For Additional Information Contact |
Dionicia B. Reblando 858-754-3700
|
Manufacturer Reason for Recall |
Did not meet finished device specifications for the DNA criteria.
|
FDA Determined Cause 2 |
Other |
Action |
Recall was by telephone on or about May 2, 2003 and by letter on May 7, 2003. Product is to be returned. |
Quantity in Commerce |
22 |
Distribution |
To hospitals nationwide. |
Total Product Life Cycle |
TPLC Device Report
|
|
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.
|
PMA Database |
PMAs with Product Code = MGR and Original Applicant = SHIRE REGENERATIVE MEDICINE
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