Recall Z-0525-2010 ยท KWP Appliance, Fixation, Spinal Interlaminal
Zimmer Inc.
Abbott Spine Thoracolumbar Common, SpdLnk 5.5 Trans Cntr Med 43-51 mm, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1302-55M. Note: This lot was not distributed in the United States. The component is used in the stabilization of constructs in the BacFix and InCompass spinal fixation systems. It is used within a temporary construct that assists normal healing and is not inte
| Date | Dec 14, 2009 (initiated Sep 21, 2009) |
| Status | Terminated |
| Reason | The titanium stock used to manufacturer the product is reported to exhibit areas of alloy segregation, which could result in a weakening of the strength of the metal. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were notified by letter dated September 21, 2009 and instructed to return the affected product to Zimmer, Inc. |
| Quantity | 13 |
| Distribution | Worldwide Distribution -- Canada, Mexico and South Africa. (Product not distributed in the United States) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002082 | SPEEDLINK TRANSVERSE CONNECTOR Spinal Concepts, Inc., Oct 6, 2000 |