Zimmer Dental recalls GemLock RHD2.5 Hex Drivers due to potential failure to engage dental implant fixtures, risking improper implant placement. Affected lot numbers: 63563072, 63572755, 63583270, 63755802.
The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
Zimmer Dental is recalling its GemLock RHD2.5 Hex Driver dental implants tools because a manufacturing issue might prevent them from securely attaching to dental implants. This could lead to improper implant placement or failure during use, which is serious for dental procedures.
The driver's hex feature might not align correctly with the implant fixture, causing it to slip or not lock properly. This could lead to improper implant placement, which may require additional surgery or cause complications.
Dental professionals who use Zimmer Dental GemLock RHD2.5 Hex Drivers for implant procedures are most at risk. Patients receiving these implants may also be affected if the tool fails during surgery.
Check the product label for lot numbers: 63563072, 63572755, 63583270, or 63755802. These drivers were sold by Zimmer Dental Inc in Carlsbad, California.
Look for the lot numbers listed: 63563072, 63572755, 63583270, or 63755802.
The device may contain a manufacturing condition affecting the geometry of the driver's hex feature, which prevents it from properly engaging the fixture mount transfer and/or dental implant.
Check the product label for the lot numbers listed. If your product has one of these lot numbers, contact Zimmer Dental for guidance.
Yes, the driver may not securely attach to dental implants, which could lead to improper implant placement or failure during use.
We’ve drafted a message you can send Zimmer Dental to request your refund or repair — edit it as you like.
Subject: Recall Z-0279-2018 — Zimmer Dental Zimmer Dental Hello, I own a Zimmer Dental that is covered by recall Z-0279-2018 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.