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U.S. Department of Health and Human Services

Class 2 Device Recall PEAK

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  Class 2 Device Recall PEAK see related information
Date Initiated by Firm May 19, 2009
Date Posted February 02, 2011
Recall Status1 Terminated 3 on April 21, 2011
Recall Number Z-1022-2011
Recall Event ID 53014
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 CA 94303-3313
For Additional Information Contact
650-331-3285
Manufacturer Reason
for Recall		 A customer reported that a patient suffered a burn while using the device.
FDA Determined
Cause 2		 Other
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 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.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = PEAK SURGICAL, INC.
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