EnDura No-React Dural Substitute 5 cm x 6 cm
This recall has been terminated (originally issued May 24, 2007).
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- May 4, 2007
- Posted
- May 24, 2007
- Terminated
- September 24, 2008
- Recall Number
- Z-0829-2007
- Quantity
- 12,736 for all recalls Z-0827-0832-2007
- Firm Location
- Plainsboro, NJ
- Official Source
- View on FDA website ↗
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
Distribution
Nationwide Distribution to hospitals and medical centers
Lot / Code Info
Product code ENR20506 : all lots
Root Cause
Other
Action Taken
On 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.