Straumann recalls Neodent Easypack Helix GM Acqua 3.5x13mm implants that were mislabeled as 3.5x8mm. This mislabeling could lead to incorrect implant placement. Affected units have specific article numbers and lot codes.
Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant
Straumann is recalling Neodent Easypack Helix GM Acqua implants that were mislabeled. The mislabeling could cause incorrect implant placement during dental procedures, which might lead to complications.
The implants were mislabeled: some boxes list 3.5x8mm instead of 3.5x13mm. Using the wrong size could lead to improper implant placement, potentially causing complications during dental procedures.
Dental professionals using the Neodent Easypack Helix GM Acqua implants with specific article numbers and lot codes. Patients receiving these implants may be at risk if the wrong size is used.
Check for the article number 138.107 and lot code GNV20 on the carton box. The UDI (Unique Device Identifier) is 7899878052906. This specific mislabeling affects implants that should be 3.5x13mm but were labeled as 3.5x8mm.
Look for the article number 138.107 and lot code GNV20 on the carton box.
The correct size is 3.5x13mm, but some units were mislabeled as 3.5x8mm.
Check for article number 138.107 and lot code GNV20 on the carton box. The UDI is 7899878052906.
No action is required for the product itself, but dental professionals should verify the correct implant size before use.
We’ve drafted a message you can send Straumann to request your refund or repair — edit it as you like.
Subject: Recall Z-0513-2022 — Straumann Straumann Hello, I own a Straumann that is covered by recall Z-0513-2022 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.
