Z-0674-2008

Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded in the following...

Name: Z-0674-2008 Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded in the following...
Creator: Orthofix, Inc
Published: 2007-09-28
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2007-09-28 / Terminated / root cause: manufacturing process

FDA source

Orthofix, Inc began a recall of Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded in the following sizes: 75mm (Catalog Number: 50-1101), 100mm (Catalog... on 2007-09-28. The reason FDA records is "Markings reversed: Graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the treatment site when adjusted". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0674-2008
Status: Terminated
Initiated: 2007-09-28
Posted: 2008-02-26
Terminated: 2008-03-20
Recalling firm: Orthofix SRL
Product: 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.
Product code: LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Orthofix notified sales agents by phone starting on 09/28/07. Sales agents were to return product for replacements.
Quantity in commerce: 69 units.
Distribution: Nationwide Distribution - USA states: CA, FL, GA, IL, PA, MI, NY and WI.
Product codes and lots: Lot numbers: For Catalog #50-1101 (75mm): 075; For Catalog #50-1014 (100mm): 7241, 076 and 50826; For Catalog #50-1015 (150mm): 2664-01, 7343 and 080; For Catalog #50-1016 (200mm): 145, 7342 and 068.

Product code LXT

K941048Class IITrue/lok Monolateral/bilateral FixatorApplied Osteo Systems, Inc. / cleared 1994-10-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)