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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Straumann Plus Initial Drill Recalled for Missing Laser Depth Engraving

Agency Publication Date: May 28, 2025
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Summary

Straumann USA LLC is recalling 288 units of the Plus Initial Drill because a specific batch was produced without a 7 mm laser depth engraving. This drill is used during dental surgery, and the missing marking could prevent clinicians from accurately measuring drilling depth. There have been no reports of incidents or injuries related to this manufacturing error.

Risk

The missing 7 mm depth engraving could lead to a clinician drilling to an incorrect depth during a procedure, potentially causing tissue damage or complications with dental implant placement.

What You Should Do

  1. The recalled product is the Straumann Plus Initial Drill, Article Number 103.170, identified by Lot Number LNWT8 and UDI-DI (01)7898237561967(11)250204(17)400204(10)LNWT8.
  2. Check your surgical inventory for the Plus Initial Drill with the specific article and lot numbers mentioned above.
  3. Stop using the recalled product immediately to avoid errors during surgical procedures.
  4. Contact Straumann USA LLC or your medical distributor to arrange for the return, replacement, or correction of the affected drills.
  5. Call the FDA at 1-888-463-6332 for more information regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Plus Initial Drill
Model / REF:
103.170
Lot Numbers:
LNWT8
UDI:
(01)7898237561967(11)250204(17)400204(10)LNWT8

Quantity affected: 288 units (47 in the US, 241 outside the US).

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96798
Status: Active
Manufacturer: Straumann USA LLC
Sold By: authorized dealers; medical distributors
Manufactured In: United States
Units Affected: 288 units ($& US, 241 OUS)
Distributed To: Arizona, California, Florida, Georgia, Illinois, Indiana, Minnesota, North Carolina, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas, Virginia, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.