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.
Recall
- Recall Number
- Z-0525-2010
- Event Number
- 53454
- Firm
- Zimmer Inc.
- FEI Number
- 1000220733
- Product Code
- KWP
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- September 21, 2009
- Posted
- December 14, 2009
- Terminated
- October 8, 2010
- Address
- 345 E Main St, Warsaw, IN, 46580-2746
Description
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.
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.
Consignees were notified by letter dated September 21, 2009 and instructed to return the affected product to Zimmer, Inc.
Worldwide Distribution -- Canada, Mexico and South Africa. (Product not distributed in the United States)
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