FDA (Devices) recall action 79396
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Implant Direct Sybron Manufacturing is recalling 1,117 Swish Tapered Implants because the packaged extender may be positioned upside down in the plastic retainer.
Implant Direct Sybron Manufacturing is recalling SwishPlus Implants because the packaged extender may be upside down in the retainer.