Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: 00841132179468 Lot Numbers: 239006-B and 238997-B
- 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:
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Product Codes/Lot Numbers:
UDI: 00841132179468 Lot Numbers: 239006-B and 238997-B
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1678-2022
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