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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Dermal Regeneration TemplateTS

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 Class 2 Recall
Integra Dermal Regeneration TemplateTS
see related information
Date Posted March 06, 2009
Recall Status1 Terminated on June 25, 2009
Recall Number Z-1035-2009
Recall Event ID 50899
Premarket Approval
PMA Number
P900033
Product Classification Device, Dermal Replacement - Product Code MDD
Product Integra Dermal Regeneration Template-TS Catalog number 32021 Catalog number 82021
Code Information Lot Numbers: 105BA0134826 and 105BB0134826. Lot Numbers: 105BY0134826 and 105BW0134826.
Recalling Firm/
Manufacturer
Integra LifeSciences Corp
105 Morgan Ln
Plainsboro, New Jersey 08536-3339
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Juith O'Grady
609-936-2375
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MDD and Applicant = INTEGRA
PMAs with Product Code = MDD and Applicant = INTEGRA LIFESCIENCES
PMAs with Product Code = MDD and Applicant = INTEGRA LIFESCIENCES CORP.
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