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Terminated

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

FDA Recall Z-0468-2011 · Posted 2010-11-26

Recalling FirmOrthohelix Surgical Designs Inc
Recall StatusTerminated
Product CodeHWX
Date Initiated2010-10-15
Date Terminated2012-09-06

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide distribution: to the states of GA and MO.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060428CSS CANNULATED SCREW SYSTEMOrthohelix Surgical Designs, Inc. · 2006-03-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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