Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 00889795114228, Lot: 5007499
- 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:
- Paragon 28, Inc.
- Reason for Recall:
- Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Product Codes/Lot Numbers:
UDI-DI: 00889795114228, Lot: 5007499
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1776-2022
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Medical devices distributed, prior to sterilization
Medical devices distributed, prior to sterilization