Recall Z-0849-06 ยท GXL Screwdriver, Skullplate
Medtronic Neurosurgery
Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self Tapping Shaft, Catalog Number 8001215 The 8001215 Screwdriver is a stainless steel part designed for use with cruciate-style screws in the firm''s TiMesh System. The product is sold in non-sterile, single unit packages. They are re-usable, and autoclavable.
| Date | May 6, 2006 (initiated Mar 8, 2006) |
| Status | Terminated |
| Reason | Medtronic Neurosurgery has initiated this action because it was determined that two lots of the Modular Screwdriver Blade components may exhiibt burrs along the tips of the Screwdriver, which may prevent adequate engagement with the associated screws. |
| Root cause | Other |
| Action | Medtronic Neurosurgery sent a Sales Representative Notification letter to the applicable Medtronic Sales Representative by mail and fax on March 8, 2006. A Sales Representative Notification Letter was provided to each Medtronic Sales Representative who had received the product or is responsible for an account who has received the product. This letter informed the applicable Sales Representative of the action and instructed them how to complete the Sales Representative Customer Product Accountability Letter. A Sales Representative Customer Product Accountability Letter was provided to each M |
| Quantity | 60 |
| Distribution | The product was distributed to the following states: Florida, Illinois, New York, Pennsylvania, Tennessee |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974017 | TIMESH SYSTEM Sofamor Danek USA,Inc., Jan 16, 1998 |