EnDura No-React Dural Substitute. Product comes in different sizes (2x10, 4x4, 5x6, 6x10, 10x12, and 12 cm diameters), s
FDA device recall Z-0588-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Shelhigh Inc
- Reason for recall
- The tamper-evident shrink band may fall off causing the user uncertainty whether the product was opened and is still sterile.
- Action taken
- Letter was sent 12/19/2003 to the 19 hospitals were the product was distributed.
- Root cause
- Other
- Status
- Terminated
- Product code
- GXQ
- Quantity affected
- 1002 units
- Distribution
- The product is distributed natiowide to 19 different hospitals.
- Date initiated
- 2003-12-19
- Date posted
- 2004-07-20
- Date terminated
- 2006-04-06
- Location
- Union, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.