Zimmer Dental recalls Tapered Screw-Vent MTX dental implants (model TSVTB10) due to potential mislabeling from manufacturing mix-ups. Affected units may have incorrect thread diameters.
Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
Zimmer Dental is recalling Tapered Screw-Vent MT: Dental Implant model TSVTB10 because two lots were accidentally mixed during production, possibly leading to mislabeling. This could mean the implants have the wrong thread size, which might cause improper fitting or complications during surgery.
During manufacturing, two different lots of implants with varying outer thread diameters were accidentally mixed. This could result in mislabeled implants that have the wrong thread size, potentially causing improper fitting or complications during dental implant surgery.
Dental surgeons and clinics using Zimmer Dental's Tapered Screw-Vent MTX implants (model TSVTB10) are likely affected. Patients undergoing dental implant procedures with these implants could be at risk if mislabeled units are used.
Check for the model number TSVTB10 on the implant packaging. Affected units include specific lot numbers: 63621027 and UDI #(01)00889024019928 (17)220331 (10)63619437.
Look for the model number TSVTB10 and specific lot numbers on the implant packaging.
Two lots of implants with different outer thread diameters were accidentally mixed during manufacturing, which could lead to mislabeling.
Check the product label for the model number TSVTB10 and specific lot numbers. If you have the affected lot numbers, contact Zimmer Dental for further instructions.
The recall is due to potential mislabeling, which could lead to improper fitting during surgery. However, the hazard is not described as causing serious injury in normal use, so the risk level is low.
We’ve drafted a message you can send Zimmer Dental to request your refund or repair — edit it as you like.
Subject: Recall Z-1189-2018 — Zimmer Dental Zimmer Dental Hello, I own a Zimmer Dental that is covered by recall Z-1189-2018 from Zimmer Dental. 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.
