Recall Z-0603-2011 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Zimmer Inc.
Spinal Concepts polyaxial screw driver, Manufactured by Spinal Concepts, Austin, TX, REF 781-01.
| Date | Dec 10, 2010 (initiated Dec 1, 2005) |
| Status | Terminated |
| Reason | The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site. |
| Root cause | Device Design |
| Action | The affected instruments were removed and replaced in the U.S. Abbott Spine and Spinal Concepts instrument kits between December 2005 and October 2007. User accounts were not advised of the removal Zimmer has confirmed that none of these instruments are currently available for use in the U.S. For further information about this action, contact Dale Miller of Zimmer at 574 372-4962. |
| Quantity | 220 |
| Distribution | Worldwide Distribution, including US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031985 | SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM Spinal Concepts, Inc., Sep 11, 2003 |
| K052247 | NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX Abbott Spine, Inc., Sep 14, 2005 |
| K052566 | NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY Abbott Spine, Inc., Jan 6, 2006 |
| K060634 | NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES Abbott Spine, Inc., Mar 31, 2006 |