FDA (Devices) recall action 78667
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.
Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
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.
Zimmer Dental Inc is recalling Tapered Screw-Vent MTX dental implants because two lots with different thread diameters were commingled and may be mislabeled.
Zimmer Dental Inc is recalling Tapered Screw-Vent MTX dental implants because two lots were inadvertently commingled during manufacturing, potentially resulting in mislabeling.