The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1862-2025·Announced 2025-06-04

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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

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.

The notice also names 23 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Straumann USA LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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