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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Padgett Electric Dermatome Set

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  Class 2 Device Recall Integra Padgett Electric Dermatome Set see related information
Date Initiated by Firm August 04, 2020
Date Posted September 12, 2020
Recall Status1 Terminated 3 on August 12, 2021
Recall Number Z-2955-2020
Recall Event ID 86240
Product Classification Dermatome - Product Code GFD
Product Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be under the supervision of trained personnel.
Code Information Catalog Number: 3539900 Catalog Description: Electric Dermatome Set Model #: S6 Lot/Serial #: S-594-6 NOT SOLD IN USA
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
1100 Campus Rd
Princeton NJ 08540-6650
For Additional Information Contact Lacey Gigante
609-212-9004
Manufacturer Reason
for Recall		 lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action All impacted consignees will be notified by letter delivered by courier service, facsimile or email about the initial notification between August 4th and 6th, 2020. Customers are asked to remove the affected product from use and complete and return the response form to the manufacturer. After response forms are reviewed the customer will be asked to return the product and a replacement will be sent.
Quantity in Commerce 2 units
Distribution Worldwide distribution - US Nationwide distribution including in the states of MN, TX, CA, UT, WV, FL, IN, GA, AZ, and the countries of Latin America ( CR, MX, TT, EC, PA ), Canada, Europe (FR, AT, BE, ES).
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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