Z-0468-2011

CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011

Name: Z-0468-2011 CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011
Creator: Orthohelix Surgical Designs Inc
Published: 2010-10-15
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2010-10-15 / Terminated / root cause: design

FDA source

Orthohelix Surgical Designs Inc began a recall of CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011 on 2010-10-15. The reason FDA records is "The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of the 5.5 and 4.0)...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0468-2011
Status: Terminated
Initiated: 2010-10-15
Posted: 2010-11-26
Terminated: 2012-09-06
Recalling firm: TORNIER Inc.
Product: CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011
Product code: HWX Tap, Bone
Reason for recall: The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of the 5.5 and 4.0) than the actual length of the buried guide wire segment and even longer (10 mm in the case of the 7.0 and 8mm in the cases of the 5.5 and 4.0) than the design intention readings. This
Root cause tag: design
FDA root cause: Device Design
Action: OrthoHelix issued an Important Recall Notice letter dated October 15, 2010 to their customers, identifying the affected products. Customers were requested to immediately return the afected devices. OrthoHelix can be contacted at 330 247-1444 concerning this recall.
Distribution: Nationwide distribution: to the states of GA and MO.
Product codes and lots: CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011

Product code HWX

K060428Class IICss Cannulated Screw SystemOrthohelix Surgical Designs, Inc. / cleared 2006-03-07

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)