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U.S. Department of Health and Human Services

Class 2 Device Recall Reprocessed Mitek Arthroscopic Wand

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 Class 2 Recall
Reprocessed Mitek Arthroscopic Wand
see related information
Date Posted March 13, 2012
Recall Status1 Terminated on May 07, 2012
Recall Number Z-1204-2012
Recall Event ID 61296
Premarket Notification
510(K) Number
K012695 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
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, Florida 33815-3113
Consumer Instructions Contact the recalling firm for information
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
PRODUCTION CONTROLS: 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = VANGUARD MEDICAL CONCEPTS, INC.
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