—#77621

Product

Integra Dermal Regeneration Template-TS Catalog number 32021 Catalog number 82021

FDA product code: MDD — Device, Dermal Replacement
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P900033
Affected lot / code info: Lot Numbers: 105BA0134826 and 105BB0134826. Lot Numbers: 105BY0134826 and 105BW0134826.

Why it was recalled

Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained.

Root cause (FDA determination)

Pending

Action the firm took

Urgent: Product Recall Notification letters were sent on January 21, 1009 via Federal Express. The letter asked customers to immediately quarantine any stock on hand and contact their local Integra Sales Representative for further assistance and arrangement of product returns. The enclosed "Recall Acknowledgement and Return Form" indicating whether or not customers possess any of the affected product should also be completed and returned. Company is conducting recall to the hospital level. Questions should be directed to Judy O'Grady at 609-936-2317.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution -- including states of FL, CA, GA, FL, CT, MT, IL, TX, WA, TN, NC, IN, AZ, MD, CO, MO, and TN.

Timeline

Recall initiated: 2009-01-16
Posted by FDA: 2009-03-06
Terminated: 2009-06-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #77621. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.