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U.S. Department of Health and Human Services

Class 2 Device Recall EnDura

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 Class 2 Device Recall EnDurasee related information
Date Initiated by FirmDecember 19, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on April 06, 2006
Recall NumberZ-0588-04
Recall Event ID 28148
Product Classification Dura Substitute - Product Code GXQ
ProductEnDura No-React Dural Substitute. Product comes in different sizes (2x10, 4x4, 5x6, 6x10, 10x12, and 12 cm diameters), sterile, stored in 2% benzyl alcohol, and distributed by Integra NeuroSciences, Plainsboro, NJ 08536.
Code Information Lot#, Catalog #, Description:  030911-NR, ENR-20210, 2CM X 10CM; 030911-NR, ENR-20404, 4CM X 4CM; 030911-NR, ENR-20506, 5CM X 6CM; 030808-NR, ENR-20610, 6CM X 10CM; 030811-NR, ENR-20610, 6CM X 10CM; 030911-NR, ENR-21012, 10CM X 12CM; 030924-NR, ENR-21012, 10CM X 12CM; 031027-NR, ENR-21212, 12CM Diameter.
FEI Number 1000081147
Recalling Firm/
Manufacturer		 Shelhigh Inc
650 Liberty Ave
Union NJ 07083-8130
For Additional Information ContactDr. Shlomo Gabbay
908-206-8706
Manufacturer Reason
for Recall		The tamper-evident shrink band may fall off causing the user uncertainty whether the product was opened and is still sterile.
FDA Determined
Cause 2		Other
ActionLetter was sent 12/19/2003 to the 19 hospitals were the product was distributed.
Quantity in Commerce1002 units
DistributionThe product is distributed natiowide to 19 different hospitals.
Total Product Life CycleTPLC 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.
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