Implant Direct recalls SwishPlus Implant 5.7mmD x 8mmL due to incorrect color coding on vials and caps, potentially causing surgical errors. Affected units have specific part numbers and were not distributed in the US.
Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.
Implant Direct is recalling SwishPlus Implant 5.7mmD x 8mmL because the color-coded vials and caps don't match the implant size described. This could lead to surgical delays, infections, or needing additional anesthesia.
The vial and cap color codes don't match the implant size listed on the vial. This confusion could cause surgeons to use the wrong implant size during surgery, leading to delays, infections, or additional anesthesia.
Surgeons who used the SwishPlus Implant 5.7mmD x 8mmL with incorrect color coding may be at risk. Patients scheduled for surgery with this implant could face complications.
Check for SwishPlus Implant 5.7mmD x 8mmL with part number 925708. The color on the vial and cap labels does not match the implant size described. No units were distributed in the US.
Check the vial and cap color codes against the implant size listed on the vial to ensure they match.
The recall is due to incorrect color coding on vials and caps that don't match the implant size described, which could cause surgical errors.
No affected devices were distributed within the US.
Check the vial and cap color codes against the implant size listed on the vial to ensure they match.
We’ve drafted a message you can send Implant Direct to request your refund or repair — edit it as you like.
Subject: Recall Z-1126-2020 — Implant Direct Implant Direct Hello, I own a Implant Direct that is covered by recall Z-1126-2020 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.
