Recall Z-2335-2010 ยท MNI Orthosis, Spinal Pedicle Fixation
Zimmer Inc.
Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1160-2. Usage: The screwdriver is intended to mate to the hexalobular feature of a PathFinder open polyaxial screw and threads onto the head to hold it in on-axis for implanting.
| Date | Aug 31, 2010 (initiated Jan 12, 2009) |
| Status | Terminated |
| Reason | The screwdriver may fracture, resulting in surgical delays and/or fragments going into the surgical site. |
| Root cause | Other |
| Action | The sales force was provided with new instructions for use on 1/12/09 and again in 05/09. On April 6, 2010 the firm sent out an Urgent Medical Device Correction to it's field representatives for distribution to it's customers. The field representatives were to distribute the forms and provide a list of the customers that recieved the recall notice. For questions or assistance, please contact Zimmer Spine at 800-326-0635. |
| Quantity | 691 |
| Distribution | Worldwide. |
| FDA record | Open on fda.gov |