FDA Device

CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031

Hazard

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

What You Should Do

Remedy

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.

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Products

CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031
Brand
Orthohelix Surgical Designs Inc
UPC
CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031

Units Affected

2

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