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Terminated

Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile; Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 USA

FDA Recall Z-2328-2008 · Posted 2008-09-20

Recalling FirmIntegra LifeSciences Corp
Recall StatusTerminated
Product CodeMDD
Date Initiated2008-07-02
Date Terminated2008-09-22
Product Quantity10 units

Reason for Recall

Product labeled with an expiration date on May 2010, while the actual expiration date should be April 2010.

Firm Action

The firm issued a letter titled URGENT-RECALL NOTICE to Integra Sales Reps on July 2, 2008. Contact Integra at 609-799-3297 if you have questions.

Root Cause

Labeling mix-ups

Distribution Pattern

Product was distributed to 5 hospitals in TN, CA, NY, IN and AL.

Official Source

View FDA Recall →

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

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