OrthoPediatrics recalls Adolescent Nail Attachment Bolt Model 01-1503-0032 due to potential binding with intramedullary nails, which may delay surgical procedures. Affected units include specific model numbers listed in the recall.
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
OrthoPediatrics is recalling a specific adolescent nail attachment bolt used in pediatric orthopedic surgery. Binding between this bolt and the intramedullary nail could delay surgical procedures, so affected users should contact the manufacturer for details.
The attachment bolt can bind with the intramedullary nail during surgery, which may cause delays in the procedure. This binding is a mechanical issue that could impact the timing of the surgery but does not pose an immediate risk of injury.
Orthopedic surgeons and medical facilities using the Adolescent Nail Attachment Bolt Model 01-1503-0032 for pediatric surgeries are most affected. Patients undergoing orthopedic procedures with this specific bolt are at risk of delayed surgery.
Check if your pediatric orthopedic surgery kit includes the model number 01-1503-0032. The affected bolt is part of the Pediatric Nailing Platform system used with intramedullary fixation rods.
Reach out to OrthoPediatrics Corp for specific instructions on how to handle the recalled bolt.
The recall indicates a potential for binding that may delay surgery, but it does not pose an immediate risk of injury or death.
The affected model number is 01-1503-0032 (Adolescent Nail Attachment Bolt).
Check if your pediatric orthopedic surgery kit includes the model number 01-1503-0032.
We’ve drafted a message you can send OrthoPediatrics to request your refund or repair — edit it as you like.
Subject: Recall Z-0219-2020 — OrthoPediatrics OrthoPediatrics Hello, I own a OrthoPediatrics that is covered by recall Z-0219-2020 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.
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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.