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.
FDA Recall Z-0525-2010 · Posted 2009-12-14
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeKWP
Date Initiated2009-09-21
Date Terminated2010-10-08
Product Quantity13
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.
Firm Action
Consignees were notified by letter dated September 21, 2009 and instructed to return the affected product to Zimmer, Inc.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution -- Canada, Mexico and South Africa. (Product not distributed in the United States)
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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