Straumann recalls GM Helix Acqua Implant (Article 140.985) due to possible 13mm implant in 11.5mm package. Check your implant size before use to avoid complications.
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 140.985) because some packages might contain a 13mm implant instead of the labeled 11.5mm size. Using the wrong size could cause complications during dental procedures.
The recall involves a potential mix-up in implant sizes. If a 13mm implant is used instead of the labeled 11.5mm, it could cause complications during dental procedures due to improper fit and function.
Dental patients who received the GM Helix Acqua Implant (Article 140.985) with a package labeled as 11.5mm but containing a 13mm implant. Patients who have had dental implants using this specific product are most at risk.
Check for the product name 'GM Helix Acqua Implant' with Article Number 140.985. Look for the UDI-DI code (01)7899878024569(11)220125(17)270124(10)JPZ75 and Lot number JPZ75 on the packaging.
Verify the actual implant size by checking the packaging for the UDI-DI code and lot number. The product may contain a 13mm implant instead of the labeled 11.5mm size.
The recall indicates a possible size mix-up, but the implant itself is not inherently dangerous. Using the wrong size could cause complications during dental procedures.
Check for the product name 'GM Helix Acqua Implant' with Article Number 140.985 and the UDI-DI code (01)7899878024569(11)220125(17)270124(10)JPZ75 on the packaging.
Verify the implant size by checking the packaging details. If you have a 13mm implant in a 11.5mm package, contact your dentist for guidance.
We’ve drafted a message you can send Straumann to request your refund or repair — edit it as you like.
Subject: Recall Z-1863-2025 — Straumann Straumann Hello, I own a Straumann that is covered by recall Z-1863-2025 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.
