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Terminated

EnDura 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.

FDA Recall Z-0588-04 · Posted 2004-07-20

Recalling FirmShelhigh Inc
Recall StatusTerminated
Product CodeGXQ
Date Initiated2003-12-19
Date Terminated2006-04-06
Product Quantity1002 units

Reason for Recall

The tamper-evident shrink band may fall off causing the user uncertainty whether the product was opened and is still sterile.

Firm Action

Letter was sent 12/19/2003 to the 19 hospitals were the product was distributed.

Root Cause

Other

Distribution Pattern

The product is distributed natiowide to 19 different hospitals.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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