Straumann recalls GM Helix Acqua Implant (Article 140.984) due to possible 11.5mm vs 13mm implant mix-up in packaging. Affected units may cause improper fit if used in dental procedures.
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Straumann is recalling GM Helix Acqua Implant (Article 140.984) because some packages might contain a 13mm implant instead of the labeled 11.5mm size. Using the wrong size could lead to improper dental implant fitting.
The recall involves a potential mix-up between 11.5mm and 13mm dental implants in the packaging. Using a 13mm implant where an 11.5mm is required could cause improper fit during dental procedures.
Dental professionals using the GM Helix Acqua Implant (Article 140.984) are likely affected. Patients receiving implants from this product may be at risk if the wrong size is used.
Check for the product name 'GM Helix Acqua Implant' and Article Number 140.984. Look for the UDI-DI code (01)7899878025290(11)220122(17)260121(10)JPZ21 and Lot number JPZ21 on the packaging.
Verify the Article Number and UDI-DI code on the packaging to confirm if it matches the recalled item.
The recall involves a potential mix-up between 11.5mm and 13mm implants, which could lead to improper fitting if used in dental procedures. However, the risk is low as the issue is limited to packaging errors.
Look for the product name 'GM Helix Acqua Implant' with Article Number 140.984 and the UDI-DI code (01)7899878025290(11)220122(17)260121(10)JPZ21 on the packaging.
The recall does not specify a remedy, so check the product details to confirm if it matches the recalled item. Contact Straumann USA LLC for further guidance.
We’ve drafted a message you can send Straumann to request your refund or repair — edit it as you like.
Subject: Recall Z-1862-2025 — Straumann Straumann Hello, I own a Straumann that is covered by recall Z-1862-2025 from Straumann. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
