FDAJanuary 9, 2019device

SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

implant direct sybron manufacturingimplantimplant direct

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708 — Recall Details · AllClear