Straumann recalls GM Helix dental implants with possible packaging mismatch. Incorrect implants could cause bone compression during installation if bone volume is sufficient.
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume
Straumann is recalling GM Helix dental implants that may have a mismatch between the implant inside packaging and the label. This could lead to bone compression or installation difficulties if there's enough bone volume.
The implant inside the packaging might not match what's labeled on the outer carton. If the wrong implant is installed, it could cause bone compression or make installation difficult when there's enough bone volume.
Dental patients who received GM Helix implants with Article No. 109.984. Patients with sufficient bone volume are at slightly higher risk of complications.
Check for the product code 'Article No. 109.984' on the packaging. The recall applies to implants sold with UDI-DI 7899878024552 lot number MVXJ9.
Verify the implant code on the packaging matches the product code 'Article No. 109.984' and lot number 'MVXJ9'.
The recall is for potential packaging mismatches that could cause bone compression or installation difficulties if there's enough bone volume. It's not an immediate safety hazard for most patients.
Check for the product code 'Article No. 109.984' and lot number 'MVXJ9' on the packaging.
No action is required if the implant matches the packaging. The recall only applies to potential mismatches, not current implants.
We’ve drafted a message you can send Straumann to request your refund or repair — edit it as you like.
Subject: Recall Z-2929-2026 — Straumann Straumann Hello, I own a Straumann that is covered by recall Z-2929-2026 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.
