Recall Z-0598-06 ยท HRS Plate, Fixation, Bone
Orthohelix Surgical Designs Inc
MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction with the MaxLock Plate and Screw System.
| Date | Mar 9, 2006 (initiated Nov 1, 2005) |
| Status | Terminated |
| Reason | Screwdriver pilot taper tip can break during surgery. |
| Root cause | Other |
| Action | Between 11/1 and 11/7/05, the recalling firm visited 12 of the consignees and collected the product, and phoned the other 2 consignees and requested return of the product. |
| Quantity | 14 |
| Distribution | Ohio, Missouri, Texas, South Dakota, Colorado, New Jersey, Georgia, and Florida. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.