The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send Implant Direct Sybron Manufacturing LLC to request your refund or repair — edit it as you like.
Subject: Recall Z-3115-2017 — Implant Direct Sybron Manufacturing LLC Implant Direct Sybron Manufacturing, LLC recalls Spectra-Sy Hello, I own a Implant Direct Sybron Manufacturing, LLC recalls Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows that is covered by recall Z-3115-2017 from Implant Direct Sybron Manufacturing LLC. 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.
