Recall Z-1204-2012 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Stryker Sustainability Solutions, Inc.
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
| Date | Mar 13, 2012 (initiated Jun 1, 2009) |
| Status | Terminated |
| Reason | 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 | 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 | 48 |
| Distribution | Nationwide Distribution (USA), including the states of: TX, NY, MN, CA, and CT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012695 | VANGUARD REPROCESSED ARTHROSCOPIC WANDS Vanguard Medical Concepts, Inc., Oct 30, 2001 |