Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) Catalog No: 7035-3005 A single use only bipolar electrosurgical instrument
FDA device recall Z-0273-2009 · posted 2008-11-05 · Terminated
Recall details
- Recalling firm
- Gyrus ACMI Corporation
- Reason for recall
- Sterility may be compromised
- Action taken
- Gyrus ACMI initiated a voluntary recall by an Urgent: Medical Device Recall letter on 10/01/08 informing accounts of the problem, cease any further use of the affected product, remove any of the affected product service representative to obtain a Return Goods Authorization, return the product, and complete the reply form and fax it to the Regulatory Affairs Dept. so that the response can be tracked.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 1340 units
- Distribution
- Worldwide Distribution --- including USA and countries of Canada, UK, Italy, Spain, Norway, Australia, and Taiwan.
- Date initiated
- 2008-10-01
- Date posted
- 2008-11-05
- Date terminated
- 2012-05-07
- Location
- Southborough, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) (K041285) | Gyrus Medical , Ltd. | 2004-09-10 |