The Reprocessed Mitek Arthroscopic Wand is considered a soft tissue ablators. Soft tissue ablators are radiofrequency (R
FDA device recall Z-1204-2012 · posted 2012-03-13 · Terminated
Recall details
- Recalling firm
- Stryker Sustainability Solutions, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 48
- Distribution
- Nationwide Distribution (USA), including the states of: TX, NY, MN, CA, and CT.
- Date initiated
- 2009-06-01
- Date posted
- 2012-03-13
- Date terminated
- 2012-05-07
- Location
- Lakeland, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VANGUARD REPROCESSED ARTHROSCOPIC WANDS (K012695) | Vanguard Medical Concepts, Inc. | 2001-10-30 |