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Class 2 Device Recall Integra Padgett Dermatome Set |
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Date Initiated by Firm |
August 04, 2020 |
Date Posted |
September 12, 2020 |
Recall Status1 |
Terminated 3 on August 12, 2021 |
Recall Number |
Z-2954-2020 |
Recall Event ID |
86240 |
Product Classification |
Dermatome - Product Code GFD
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Product |
Integra Padgett 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: 3539700 Catalog Description: Slimline Dermatome Set Model #: S Lot/Serial #: S-1949, S-1919, S-1930 to S-1932, S-1937 to S-1939, S-1944 to S-1946 ***Updated 5/3/21*** S-1927, S-1928 |
Recalling Firm/ Manufacturer |
Integra LifeSciences Corp. 1100 Campus Rd Princeton NJ 08540-6650
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For Additional Information Contact |
Lacey Gigante 609-212-9004
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Manufacturer Reason for Recall |
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
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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 |
13 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
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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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