Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded in the following sizes: 75mm (Cat
FDA device recall Z-0674-2008 · posted 2008-02-26 · Terminated
Recall details
- Recalling firm
- Orthofix, Inc
- 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.
- Action taken
- Orthofix notified sales agents by phone starting on 09/28/07. Sales agents were to return product for replacements.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LXT
- Quantity affected
- 69 units.
- Distribution
- Nationwide Distribution - USA states: CA, FL, GA, IL, PA, MI, NY and WI.
- Date initiated
- 2007-09-28
- Date posted
- 2008-02-26
- Date terminated
- 2008-03-20
- Location
- Mckinney, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRUE/LOK MONOLATERAL/BILATERAL FIXATOR (K941048) | Applied Osteo Systems, Inc. | 1994-10-03 |