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.
This recall has been terminated (originally issued February 26, 2008).
- Company
- Orthofix, Inc
- Recall Initiated
- September 28, 2007
- Posted
- February 26, 2008
- Terminated
- March 20, 2008
- Recall Number
- Z-0674-2008
- Quantity
- 69 units.
- Firm Location
- Mckinney, TX
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution - USA states: CA, FL, GA, IL, PA, MI, NY and WI.
Lot / Code Info
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.
Root Cause
Process control
Action Taken
Orthofix notified sales agents by phone starting on 09/28/07. Sales agents were to return product for replacements.