Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufactured at Warsaw, Indiana; REF
FDA device recall Z-0114-2008 · posted 2007-11-07 · Terminated
Recall details
- Recalling firm
- Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
- Reason for recall
- Packaging weakness may compromise sterility and instructions for use are inadequate.
- Action taken
- Consignees were notified via letter dated September 4, 2007 to cease using the product and to contact the firm for instructions on how to return the product.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 22,632
- Distribution
- Worldwide, including USA, Hong Kong, India, Mexico, Netherlands, Qatar, Saudi Arabia and South Korea.
- Date initiated
- 2007-09-04
- Date posted
- 2007-11-07
- Date terminated
- 2009-07-14
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STEALTH SURGICAL IRRIGATOR ASPIRATOR (K930511) | W. J. Medical Instruments, Inc. | 1993-06-25 |