OrthoPediatrics recalls Orthex External Fixation Wire Model K400-18BN due to fracture risk that could delay surgery and cause tissue damage. Affected units have specific lot numbers.
Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase healing time
OrthoPediatrics is recalling a specific type of bone fixation wire because a manufacturing issue might cause the wire tip to break. If the broken tip stays in the patient, it could delay surgery and cause tissue damage during removal attempts.
The wire tip can fracture due to a manufacturing variance near the transition point. If the broken tip remains in the patient, doctors may need to attempt removal, which could delay surgery and damage surrounding soft tissues, increasing healing time.
Orthopedic surgeons and medical staff using the Orthex External Fixation Wire Model K400-18BN for bone surgery. Patients with this specific model are at risk if the wire fractures during treatment.
Check for the model number K400-18BN on the wire. Affected units have lot numbers 239006-B and 238997-B. The wire is 1.8 mm diameter and 400 mm long.
Inspect the wire tip for signs of fracture or manufacturing defects. If the tip appears damaged, stop using it immediately.
Yes, if the wire tip fractures and remains in the patient, it could delay surgery and cause tissue damage during removal attempts.
Check the model number and lot numbers. If it matches K400-18BN with lot numbers 239006-B or 238997-B, contact OrthoPediatrics for guidance.
Only if you check the model and lot numbers first. If it matches the recalled items, stop using it and contact OrthoPediatrics.
We’ve drafted a message you can send OrthoPediatrics to request your refund or repair — edit it as you like.
Subject: Recall Z-1678-2022 — OrthoPediatrics OrthoPediatrics Hello, I own a OrthoPediatrics that is covered by recall Z-1678-2022 from OrthoPediatrics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
