—#72417

Product

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 product code: MDD — Device, Dermal Replacement
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P900033
Affected lot / code info: Catalog Number 38101, Lot Number 105BA0121823

Why it was recalled

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

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp
Address: 105 Morgan Ln, Plainsboro, New Jersey 08536-3339

Distribution

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

Timeline

Recall initiated: 2008-07-02
Posted by FDA: 2008-09-20
Terminated: 2008-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72417. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.