ImplantDirect recalls a specific size 4.3mmD x 13mmL implant due to incorrect packaging in vials. Affected units have a specific lot number and label details. Consumers should contact the manufacturer for guidance.
The incorrect device was packaged in the vial.
ImplantDirect is recalling a specific size 4.3mmD x 13mmL RePlant implant because it was packaged incorrectly in vials. This could lead to improper use if the wrong implant is used during medical procedures.
The implant was packaged incorrectly in vials, which could mean the wrong implant is used during medical procedures. This might lead to improper treatment if the incorrect device is implanted.
Patients who received this specific implant size and lot number from the manufacturer. Medical professionals using this implant for procedures are at risk of using the incorrect device.
Check the label for the firm name 'Implant Direct Sybron Manufacturing LLC' and lot number 108191. The product has a specific reference number REF 604313U and is sterile.
Reach out to Implant Direct Sybron Manufacturing LLC for guidance on whether the implant is affected.
The recall states the device was packaged incorrectly, but the official notice does not specify if it is safe to use.
The official notice does not provide specific action steps for affected users.
Check the label for the firm name 'Implant Direct Sybron Manufacturing LLC' and lot number 108191.
We’ve drafted a message you can send Implant Direct to request your refund or repair — edit it as you like.
Subject: Recall Z-0010-2020 — Implant Direct Implant Direct Hello, I own a Implant Direct that is covered by recall Z-0010-2020 from Implant Direct. 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.
