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U.S. Department of Health and Human Services

Class 1 Device Recall Endura NoReact

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 Class 1 Device Recall Endura NoReactsee related information
Date Initiated by FirmMay 04, 2007
Date PostedMay 24, 2007
Recall Status1 Terminated 3 on September 24, 2008
Recall NumberZ-0831-2007
Recall Event ID 37903
Product Classification Dural Substitute - Product Code DTZ
ProductEnDura No React Dural Substitute 10 cm x 12 cm
Code Information Product code: ENR21012: all lots
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information ContactJudith E. O'Grady
609-936-2311
Manufacturer Reason
for Recall		Integra LifeSciences Corporation d/b/a Integra NeuroSciences, the distributor of EnDura No-React Dural Substitute, manufactured by Shelhigh, Inc., Union, NJ, is recalling this product based on an FDA Public Health Notification and FDA requested recall letter to Shelhigh citing sterility and other manufacturing concerns regarding this product manufactured by Shelhigh. Integra is a distributor of t
FDA Determined
Cause 2		Other
ActionOn May 4, 2007, an Urgent Recall Notice and accompanying recall acknowledgement form was sent to all customers that had purchased or been supplied EnDura No-React Dural Substitute product since sale of the product was initiated in 2003. Recall Coordinators at each facility are asked to review inventory for EnDura products and to call Integra Customer Service for an authorization number for return of product.
Quantity in Commerce12,736 for all recalls Z-0827-0832-2007
DistributionNationwide Distribution to hospitals and medical centers
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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