FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number: M1505053
- 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:
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Reason for Recall:
- Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Product Codes/Lot Numbers:
Lot Number: M1505053
Distribution:
Distributed in: US, TX, OH, MI, ME, FR, DE, SK, IT, NL, CH, CZ
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0657-2016
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