Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SwishPlus Implant 5.7mmD x 8mmL Recalled by Implant Direct Sybron Manufacturing LLC Due to Due to a complaint received and internal investigation...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Implant Direct Sybron Manufacturing LLC directly.
Affected Products
SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
Quantity: 11 units
Why Was This Recalled?
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.
Where Was This Sold?
US: None OUS: Iceland, Sweden, Spain,
About Implant Direct Sybron Manufacturing LLC
Implant Direct Sybron Manufacturing LLC has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report