Recall Z-0468-2011 ยท HWX Tap, Bone
Orthohelix Surgical Designs Inc
CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011
| Date | Nov 26, 2010 (initiated Oct 15, 2010) |
| Status | Terminated |
| Reason | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060428 | CSS CANNULATED SCREW SYSTEM Orthohelix Surgical Designs, Inc., Mar 7, 2006 |