OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Number: 10-1500-3048 Lot Number: 161421-G
- 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:
- Labeled as a 48mm Cortical Screw but measuring at 50mm
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
Product Codes/Lot Numbers:
Product Number: 10-1500-3048 Lot Number: 161421-G
Distribution:
Distributed in: US, TX, MO, FL, GA, NC, AZ, NY
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0879-2017
Related Recalls
Orthex Large Bone Shoulder Bolt, model no. AS-17
OrthoPediatrics
Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration.
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
Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device