TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Class I - DangerousWhat Should You Do?
- Check if you have this product: REF: 037.3002; UDI-DI: 07630031750587; Packaging Lot number: LGMZ8, GLKJ9; Lot number engraved on part: HTXT5.
- 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:
- Straumann USA LLC
- Reason for Recall:
- The devices are missing the laser marked depth markings.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Product Codes/Lot Numbers:
REF: 037.3002; UDI-DI: 07630031750587; Packaging Lot number: LGMZ8, GLKJ9; Lot number engraved on part: HTXT5.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1561-2025
Related Recalls
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
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Plus Initial Drill, Article Number: 103.170;
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The referred batch was produced without the laser engraving of 7 mm.