The Recall Desk
HighFDA (Devices)·Z-1863-2025·Announced 2025-06-04

Dental Implant Size Labeling Error Discovered in GM Helix Acqua Units

Straumann USA is recalling GM Helix Acqua Implants because some packages labeled as 11.5 mm may contain 13 mm implants instead. This size discrepancy could lead to improper implantation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device recall where size discrepancies in dental implants directly affect surgical outcomes. No injuries have been reported to date, which per the rubric keeps this at High rather than Severe, but the packaging error affecting 207 units creates a real patient-safety risk if not caught before implantation.

Plain-English summary

Straumann USA LLC is recalling GM Helix Acqua Implants (Article Number 140.985) due to a labeling discrepancy. Some packages labeled as containing 11.5 mm implants may actually contain 13 mm implants instead. A total of 207 units are affected by this packaging error.

The mislabeling creates a risk that healthcare professionals could implant the wrong-sized implant during surgical procedures. While no injuries have been reported to date, size discrepancies in dental implants can affect the surgical outcome and implant fit.

The affected implants were distributed worldwide, including to facilities in the United States (in Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Rhode Island, South Carolina, Tennessee, Texas, Utah, and Wisconsin) and internationally to Australia, Croatia, France, Hungary, India, Italy, Lebanon, Lithuania, New Zealand, Portugal, Qatar, Serbia, Spain, Tunisia, United Arab Emirates, United Kingdom, and Vietnam.

Patients or healthcare providers who have received GM Helix Acqua Implants (Article Number 140.985) should verify the actual implant size against the package labeling before surgery. Contact Straumann USA LLC or your healthcare provider if you have questions about your implant.

The recalled product

Product
GM Helix Acqua Implant, Article Number: 140.985
Manufacturer
Straumann USA LLC
Category
Medical Device — Dental Implant
Hazard
  • size-mismatch
  • labeling-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Article Number: 140.985
  • UDI-DI: (01)7899878024569(11)220125(17)270124(10)JPZ75
  • Lot number: JPZ75

Distribution

Distributed nationwide across the United States.

Related recalls

Same category