Z-0747-06

METRx II Tube, 22mm x 3cm stainless steel tubular retractor, Part No. 9569730

Name: Z-0747-06 METRx II Tube, 22mm x 3cm stainless steel tubular retractor, Part No. 9569730
Creator: Medtronic Sofamor Danek Instrument Manufacturing
Published: 2006-01-25
License: https://open.fda.gov/license/

Medtronic Sofamor Danek Instrument Manufacturing / initiated 2006-01-25 / Terminated / root cause: manufacturing process

FDA source

Medtronic Sofamor Danek Instrument Manufacturing began a recall of METRx II Tube, 22mm x 3cm stainless steel tubular retractor, Part No. 9569730 on 2006-01-25. The reason FDA records is "Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0747-06
Status: Terminated
Initiated: 2006-01-25
Posted: 2006-04-12
Terminated: 2007-07-05
Recalling firm: Medtronic Sofamor Danek Instrument Manufacturing
Product: METRx II Tube, 22mm x 3cm stainless steel tubular retractor, Part No. 9569730
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off.
Root cause tag: manufacturing process
FDA 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 in commerce: 1
Distribution: IL, IN, MI, CA, Japan, Netherlands
Product codes and lots: LOt No. DC05L005

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)