—#87613

Product

Spinal Concepts polyaxial screw driver, Manufactured by Spinal Concepts, Austin, TX, REF 781-01.

FDA product code: KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K031985, K052247, K052566, K060634
Affected lot / code info: Lots 16HU, 18FL, 19GC, 21BS and 29CK.

Why it was recalled

The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.

Root cause (FDA determination)

Device Design

Action the firm took

The affected instruments were removed and replaced in the U.S. Abbott Spine and Spinal Concepts instrument kits between December 2005 and October 2007. User accounts were not advised of the removal Zimmer has confirmed that none of these instruments are currently available for use in the U.S. For further information about this action, contact Dale Miller of Zimmer at 574 372-4962.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution, including US.

Timeline

Recall initiated: 2005-12-01
Posted by FDA: 2010-12-10
Terminated: 2011-06-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #87613. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.