—#85554

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.

FDA product code: KWP — Appliance, Fixation, Spinal Interlaminal
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K002082
Affected lot / code info: Lot 55QJ.

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

Consignees were notified by letter dated September 21, 2009 and instructed to return the affected product to Zimmer, Inc.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Worldwide Distribution -- Canada, Mexico and South Africa. (Product not distributed in the United States)

Timeline

Recall initiated: 2009-09-21
Posted by FDA: 2009-12-14
Terminated: 2010-10-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85554. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.