Date Initiated by Firm | June 01, 2009 |
Date Posted | March 13, 2012 |
Recall Status1 |
Terminated 3 on May 07, 2012 |
Recall Number | Z-1204-2012 |
Recall Event ID |
61296 |
510(K)Number | K012695 |
Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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Product | The Reprocessed Mitek Arthroscopic Wand is considered a soft tissue ablators. Soft tissue ablators are radiofrequency (RF) surgical tools designed for removal and dissection of tissue in arthroscopic surgeries. A generator or controller serves as the power unit. Soft tissue ablators are available in a wide range of sizes and angles; some models include thermal or suction functions.
The outer box of the Reprocessed Mitek Arthroscopic Wand is labeled in part: "***ASCENT HEALTHCARE SOLUTIONS Lakeland, FL***Contents sterile by EO unless package is opened or damaged.***Reprocessed Device for single use. Reprocessed By Ascent Healthcare Solutions.***Cat #: 225301 MITEK 3.5mm SIDE EFFECT ELECTRODE***Lot #: 674290 Expiration Date: 04/2012***"
Individual pouch labeled in part: "***Cat #: 225301***MITEK 3.5mm SIDE EFFECT ELECTRODE****IFU at www.ascenths.com***Contents: One Expiration Date 04/2012***Lot # 674201 ID# 0***Reprocessed by Ascent Healthcare Solutions Not affiliated with the original manufacturer.***ASCENT HEALTHCARE SOLUTIONS Lakeland, FL***" |
Code Information |
Model # 225301 Lot #s: 674201 & 674290 Expiration dates: 04/2012 |
Recalling Firm/ Manufacturer |
Stryker Sustainability Solutions, Inc. 5307 Great Oak Dr Lakeland FL 33815-3113
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For Additional Information Contact | Moira Barton-Varty 888-888-3433 Ext. 5519 |
Manufacturer Reason for Recall | On 06/09/2009, Stryker Sustain ability Solutions, formerly Ascent Healthcare Solutions, recalled lots 674201 & 674290 of their Reprocessed Mitek Arthroscopic Wand due to the lots not being tested in accordance with the functional test requirement during the time frame of 04/14/09 to 05/25/09. |
FDA Determined Cause 2 | Process control |
Action | Ascent Healthcare Solutions notified their customers by presenting a letter dated June 1, 2009 from an Ascent Representative. The representative was to recover any products that may have been affected. Questions were directed to 1-888-888-3433. |
Quantity in Commerce | 48 |
Distribution | Nationwide Distribution (USA), including the states of: TX, NY, MN, CA, and CT. |
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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