Spinal Concepts snap-fix polyaxial screwdriver, Manufactured by Spinal Concepts, Austin, TX, REF 781-3.
FDA device recall Z-0605-2011 · posted 2010-12-10 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 26
- Distribution
- Worldwide Distribution, including US.
- Date initiated
- 2005-12-01
- Date posted
- 2010-12-10
- Date terminated
- 2011-06-01
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES (K060634) | Abbott Spine, Inc. | 2006-03-31 |
| NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY (K052566) | Abbott Spine, Inc. | 2006-01-06 |
| NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX (K052247) | Abbott Spine, Inc. | 2005-09-14 |
| SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM (K031985) | Spinal Concepts, Inc. | 2003-09-11 |