| Class 2 Device Recall PEAK | |
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
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = GEI
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