Straumann recalls certain Bone Level Tapered implants that may be 12mm instead of 14mm. This could cause improper fit and complications during dental surgery. Affected implants have specific model numbers and lot codes.
Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.
Straumann is recalling dental implants that might be 12mm long instead of the labeled 14mm. This could lead to improper fit during dental procedures and potential complications. The recall affects specific implant models with known lot numbers.
The implants may be 12mm instead of 14mm as labeled, which could cause improper fit during dental procedures. This might lead to complications like delayed healing or the need for additional surgeries. However, the risk is not immediate and does not cause serious injury in normal use.
Dental patients who received the recalled Straumann Bone Level Tapered implants (D 4.1mm RC, SLActive 14mm, Roxolid, Loxim) with lot code ZVFV5 are most at risk. The recall applies to implants sold in the U.S. between specific dates.
Check for the model name 'Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim' and lot code ZVFV5. The recall applies to implants with UDI/DI number 7630031707055.
Look for the model name and lot code on your implant to see if it matches the recalled items.
The implants may be 12mm instead of 14mm as labeled, which could cause improper fit during dental procedures.
Check your implant's model and lot code to see if it matches the recalled items. If it does, contact Straumann for further instructions.
The recall does not indicate a risk of serious injury in normal use. The hazard is a potential fit issue that may require additional procedures.
We’ve drafted a message you can send Straumann to request your refund or repair — edit it as you like.
Subject: Recall Z-2935-2026 — Straumann Straumann Hello, I own a Straumann that is covered by recall Z-2935-2026 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.