Straumann GM Helix Acqua Implants Recalled for Size Mislabeling
Straumann USA LLC recalls 300 units of GM Helix Acqua Implants due to packaging labeling errors. Packages labeled as 11.5 mm implants may contain 13 mm implants instead, affecting proper surgical placement.
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 an FDA Class II recall with no reported illnesses or injuries. The size mismatch represents a risk-of-harm product where a labeling discrepancy could result in incorrect implant placement during surgery, but actual harm has not been documented.
Plain-English summary
Straumann USA LLC is recalling 300 units of the GM Helix Acqua Implant (Article Number 140.984, Lot JPZ21) due to a labeling discrepancy in the product packaging.
Packages labeled as containing 11.5 mm implants may instead contain 13 mm implants. This size mismatch could result in an incorrect implant being used during surgery, affecting proper placement and long-term performance.
The affected implants have been distributed across the United States and internationally. In the U.S., 125 units were distributed across 22 states. An additional 175 units were distributed internationally.
Healthcare providers and patients who have received these implants should verify the actual implant size matches the package labeling before surgical use. Contact Straumann USA LLC if you have questions about your implants.
The recalled product
- Product
- GM Helix Acqua Implant, Article Number: 140.984
- 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: 140.984
- UDI-DI: (01)7899878025290(11)220122(17)260121(10)JPZ21
- Lot number: JPZ21
Distribution
Distributed nationwide across the United States.
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