GM Helix Acqua Implant labeled 11.5 mm may contain 13 mm
Straumann USA LLC is recalling GM Helix Acqua Implants (Article Number 140.984) because packages labeled as 11.5 mm implants may contain 13 mm implants instead.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling error with no reported illnesses or injuries. The hazard is procedural—wrong implant size—but the source text contains no evidence of actual harm, meeting the Moderate severity criterion for minor labeling errors without reported adverse events.
Plain-English summary
Straumann USA LLC is recalling the GM Helix Acqua Implant (Article Number 140.984, Lot JPZ21) due to a labeling error. Some packages labeled as 11.5 mm implants may actually contain 13 mm implants instead.
This discrepancy could result in the wrong implant size being used, which may affect the outcome of the surgical procedure. The recalled product was distributed worldwide, including across the United States in the following states: 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. International distribution included Australia, Croatia, France, Hungary, India, Italy, Lebanon, Lithuania, New Zealand, Portugal, Qatar, Serbia, Spain, Tunisia, the United Arab Emirates, the United Kingdom, and Vietnam.
Healthcare providers and patients who may have received or implanted products from Lot JPZ21 with Article Number 140.984 should verify the actual implant size against the package label. Contact Straumann USA LLC if you have questions about whether your implant may be affected by this recall.
The recalled product
- Product
- GM Helix Acqua Implant, Article Number: 140.984
- Manufacturer
- Straumann USA LLC
- Category
- Medical Device — Dental Implant
- Hazard
- mis-labeling
- size-mismatch
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: 140.984
- UDI-DI: (01)7899878025290(11)220122(17)260121(10)JPZ21
- Lot number: JPZ21
Distribution
Distributed nationwide across the United States.
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