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Terminated

Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 37MM, spinal implant component

FDA Recall Z-0444-2010 · Posted 2009-11-24

Recalling FirmStryker Spine
Recall StatusTerminated
Product CodeKWQ
Date Initiated2009-10-02
Date Terminated2013-01-23
Product Quantity257

Reason for Recall

Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break at the tip.

Firm Action

Recall notification letters were sent to all Stryker branches, Hospital Risk Management and Surgeons on October 19, 2009 by Federal Express. Questions are to be directed to Tiffani Rogers, Regulatory Compliance Manager at 201-760-8206.

Root Cause

Device Design

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K073437THOR ANTERIOR PLATING SYSTEMStryker Spine · 2008-02-13

Official Source

View FDA Recall →

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

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