FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek Instrument Manufacturing: METRx II Tube, 22mm x 5cm stainless steel tubular retractor, Part No. 9569732
- Recall number
- Z-0749-06
- Recalling firm
- Medtronic Sofamor Danek Instrument Manufacturing
- Product
- METRx II Tube, 22mm x 5cm stainless steel tubular retractor, Part No. 9569732
- Status
- Terminated
- Initiated
- 2006-01-25
- Posted
- 2006-04-12
- Terminated
- 2007-07-05
- Reason
- Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off.
- Root cause
- Other
- Action
- The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
- Quantity
- 2
- Distribution
- IL, IN, MI, CA, Japan, Netherlands
- Lot, serial or model codes
- Lot No. DC05L007
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3004564008
- Firm city
- Bartlett
- Firm state
- TN
- 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