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

FDA device recall Z-1035-2009 · posted 2009-03-06 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp

Reason for recall

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.

Action taken

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.

Root cause

Pending

Status

Terminated

Product code

MDD

Quantity affected

31 units

Distribution

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

Date initiated

2009-01-16

Date posted

2009-03-06

Date terminated

2009-06-25

Location

Plainsboro, NJ