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Terminated

Spinal Concepts polyaxial screwdriver II, Manufactured by Spinal Concepts, Austin, TX, REF 781-2.

FDA Recall Z-0604-2011 · Posted 2010-12-10

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeKWQ
Date Initiated2005-12-01
Date Terminated2011-06-01
Product Quantity27

Reason for Recall

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

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution, including US.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060634NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIESAbbott Spine, Inc. · 2006-03-31K052566NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SYAbbott Spine, Inc. · 2006-01-06K052247NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XXAbbott Spine, Inc. · 2005-09-14K031985SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEMSpinal Concepts, Inc. · 2003-09-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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