Z-0525-2010

Abbott Spine Thoracolumbar Common, SpdLnk 5.5 Trans Cntr Med 43-51 mm, non-sterile, Manufactured by Abbott...

Name: Z-0525-2010 Abbott Spine Thoracolumbar Common, SpdLnk 5.5 Trans Cntr Med 43-51 mm, non-sterile, Manufactured by Abbott...
Creator: Zimmer Inc.
Published: 2009-09-21
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-09-21 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of 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... on 2009-09-21. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0525-2010
Status: Terminated
Initiated: 2009-09-21
Posted: 2009-12-14
Terminated: 2010-10-08
Recalling firm: Zimmer GmbH
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.
Product code: KWP Appliance, Fixation, Spinal Interlaminal
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 13
Distribution: Worldwide Distribution -- Canada, Mexico and South Africa. (Product not distributed in the United States)
Product codes and lots: Lot 55QJ.

Product code KWP

K002082Class IISpeedlink Transverse ConnectorSpinal Concepts, Inc. / cleared 2000-10-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)