Zimmer Dental recalls TSV4B10 dental implants due to potential mislabeling from manufacturing mix-up. 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 MTX dental implants (model TSV4B1:0) because two lots were accidentally mixed during production, possibly leading to mislabeling. This could mean the implants have incorrect thread sizes, which might cause improper fitting or complications during surgery.
The implants were accidentally mixed during manufacturing, causing some units to have different outer thread diameters than labeled. This mislabeling could lead to incorrect implant fitting during surgery, potentially causing complications like improper bone integration or surgical errors.
Dental surgeons and clinics that purchased the TSV4B10 model implants with lot numbers 63619437 or UDI (01)00889024019225 are most at risk. Patients receiving these implants may face improper fitting if the thread size is incorrect.
Check for the model number TSV4B10 on the implant packaging. Affected units include lot number 63619437 or the unique device identifier (UDI) (01)00889024019225.
Look for the model number TSV4B10 and lot number 63619437 or UDI (01)00889024019225 on the implant packaging.
Two lots of the Tapered Screw-Vent Implants were inadvertently commingled during manufacturing, potentially causing mislabeling with incorrect thread diameters.
Check the product label for the model number TSV4B10 and lot number 63619437 or UDI (01)00889024019225. If you have these identifiers, contact Zimmer Dental for further instructions.
The recall addresses potential mislabeling that could lead to improper fitting during surgery, but the risk of serious injury is low as the hazard is related to manufacturing mix-up, not inherent product failure.
We’ve drafted a message you can send Zimmer Dental to request your refund or repair — edit it as you like.
Subject: Recall Z-1190-2018 — Zimmer Dental Zimmer Dental Hello, I own a Zimmer Dental that is covered by recall Z-1190-2018 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.
