Straumann recalls Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 dental implants due to mislabeling. The 3.5x8mm implant is incorrectly labeled as 3.5x13mm, which could cause improper implant placement.
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 dental implants because they are mislabeled. Using the wrong size implant could lead to improper placement during dental procedures.
The product is mislabeled: the carton box for item 138.089 lists a 3.5x8mm implant but the actual implant is 3.5x13mm. This size difference could cause improper implant placement during dental procedures if used without verification.
Dental professionals who purchased the Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 implant (Item 138.089) with lot number GNV17. Patients receiving dental implants using this specific model are at risk of incorrect implant placement.
Check for the carton box item number 138.089 with lot number GNV17 and UDI code 7899878052722. The product is intended for dental implants and is mislabeled as having a 3.5x8mm implant when it is actually 3.5x13mm.
Check the carton box item number (138.089) and lot number (GNV17) to confirm you have the mislabeled implant.
The product is mislabeled: the carton box for item 138.089 lists a 3.5x8mm implant but the actual implant is 3.5x13mm, which could cause improper implant placement.
The recall record does not specify a remedy, so you should verify the product details and contact Straumann USA LLC for further guidance.
The recall indicates a mislabeling issue that could lead to improper implant placement, so it is not safe to use without verification.
We’ve drafted a message you can send Straumann to request your refund or repair — edit it as you like.
Subject: Recall Z-0512-2022 — Straumann Straumann Hello, I own a Straumann that is covered by recall Z-0512-2022 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.
