Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 175221-A 177577-A 183280-A 187375-A 189808-A 192279-B 192432-B 198082-C
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- OrthoPediatrics Corp
- Reason for Recall:
- Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.
Product Codes/Lot Numbers:
175221-A 177577-A 183280-A 187375-A 189808-A 192279-B 192432-B 198082-C
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0219-2020
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