Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Number: 110010851 Lot Number: 139800, 139810, 139820
- 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:
- Biomet, Inc.
- Reason for Recall:
- An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
Product Codes/Lot Numbers:
Catalog Number: 110010851 Lot Number: 139800, 139810, 139820
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0058-2015
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