Recall Z-0674-2008 ยท LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Orthofix, Inc
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.
| Date | Feb 26, 2008 (initiated Sep 28, 2007) |
| Status | Terminated |
| Reason | 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 | Process control |
| Action | Orthofix notified sales agents by phone starting on 09/28/07. Sales agents were to return product for replacements. |
| Quantity | 69 units. |
| Distribution | Nationwide Distribution - USA states: CA, FL, GA, IL, PA, MI, NY and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K941048 | TRUE/LOK MONOLATERAL/BILATERAL FIXATOR Applied Osteo Systems, Inc., Oct 3, 1994 |