FDA Medical Device Recalls (openFDA)
Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK: Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufactured at Warsaw, Indiana; REF (P/N) 9560575.
- Recall number
- Z-0114-2008
- Recalling firm
- Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
- Product
- Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufactured at Warsaw, Indiana; REF (P/N) 9560575.
- Status
- Terminated
- Initiated
- 2007-09-04
- Posted
- 2007-11-07
- Terminated
- 2009-07-14
- Reason
- Packaging weakness may compromise sterility and instructions for use are inadequate.
- Root cause
- Package design/selection
- Action
- 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.
- Quantity
- 22,632
- Distribution
- Worldwide, including USA, Hong Kong, India, Mexico, Netherlands, Qatar, Saudi Arabia and South Korea.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- ["K930511"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1824199
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28