Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded in the following sizes: 75mm (Catalog Number: 50-1101), 100mm (Catalog Number: 50-1014), 150mm (Catalog Number: 50-1015) and 200mm (Catalog Number: 50-1016), distributed by Orthofix, Inc., McKinney, TX 75069.
FDA Recall Z-0674-2008 · Posted 2008-02-26
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Recalling FirmOrthofix, Inc
Recall StatusTerminated
Product CodeLXT
Date Initiated2007-09-28
Date Terminated2008-03-20
Product Quantity69 units.
Reason for Recall
Markings reversed: Graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the treatment site when adjusted.
Firm Action
Orthofix notified sales agents by phone starting on 09/28/07. Sales agents were to return product for replacements.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution - USA states: CA, FL, GA, IL, PA, MI, NY and WI.
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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