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U.S. Department of Health and Human Services

Class 2 Device Recall PEAK

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 Class 2 Recall
PEAK
see related information
Date Posted February 02, 2011
Recall Status1 Terminated on April 21, 2011
Recall Number Z-1022-2011
Recall Event ID 53014
Premarket Notification
510(K) Number
K082786 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product PEAK brand PlasmaBlade EXT, Tissue Dissection Device, Catalogue Number: PS215-040; Product is manufactured and distributed by PEAK Surgical, Palo Alto, CA The PEAK Surgery System is indicated for the cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopedic, Arthroscopic, Spinal and Neurological procedures.
Code Information Lot Numbers: 11673, 12061, 12237, 12393, 12485
Recalling Firm/
Manufacturer
Peak Surgical
2464 Embarcadero Way
Palo Alto, California 94303-3313
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
A customer reported that a patient suffered a burn while using the device.
Action Peak Surgical notified afftected customers by phone on May 19, 2009. They were notified of the product, the problem, and the action to be taken. Peak Surgical sales representatives removed PlasmaBlade EXT devices from consignees affected by the recall.
Quantity in Commerce 493 units
Distribution Worldwide Distribution - United States including CA, CO, FL, IL, MD, MN, NV, NY, OH, OK, TN, TX, UT, and WAand the countries of Turkey and Ireland
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
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = PEAK SURGICAL, INC.
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