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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Orthofix, Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Orthofix, Inc is recalling Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded in the follow due to Markings reversed: Graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the trea. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Markings reversed: Graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the treatment site when adjusted.
Recommended Action
Per FDA guidance
Orthofix notified sales agents by phone starting on 09/28/07. Sales agents were to return product for replacements.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026