Z-1204-2012

The Reprocessed Mitek Arthroscopic Wand is considered a soft tissue ablators. Soft tissue ablators are...

Name: Z-1204-2012 The Reprocessed Mitek Arthroscopic Wand is considered a soft tissue ablators. Soft tissue ablators are...
Creator: Stryker Sustainability Solutions, Inc.
Published: 2009-06-01
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2009-06-01 / Terminated / root cause: manufacturing process

FDA source

Stryker Sustainability Solutions, Inc. began a recall of The Reprocessed Mitek Arthroscopic Wand is considered a soft tissue ablators. Soft tissue ablators are radiofrequency (RF) surgical tools designed for removal... on 2009-06-01. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1204-2012
Status: Terminated
Initiated: 2009-06-01
Posted: 2012-03-13
Terminated: 2012-05-07
Recalling firm: Stryker Sustainability Solutions
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***"
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Model # 225301 Lot #s: 674201 & 674290 Expiration dates: 04/2012

Product code GEI

K012695Class IIVanguard Reprocessed Arthroscopic WandsVanguard Medical Concepts, Inc. / cleared 2001-10-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)