Recall Z-0525-2010
Zimmer Inc. · initiated September 21, 2009
Product
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 intended to replace normal body structures.
Codes / lots: Lot 55QJ.
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
Consignees were notified by letter dated September 21, 2009 and instructed to return the affected product to Zimmer, Inc.
Details
- Recall number
- Z-0525-2010
- Initiated
- September 21, 2009
- Posted by FDA
- December 14, 2009
- Terminated
- October 8, 2010
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Quantity
- 13
- Distribution
- Worldwide Distribution -- Canada, Mexico and South Africa. (Product not distributed in the United States)
- Recalling firm
- Zimmer Inc., Warsaw, IN