FDA (Devices) recall action 70628
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
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.
Biomet 3i is recalling 620 OSSEOTITE Tapered dental implants because contact with residual machine fluid caused discoloration.
Biomet 3i, LLC is recalling 620 T3 Non-Platform Switched Tapered Dental Implants because contact with residual machine fluid caused discoloration.
Biomet 3i is recalling 620 OSSEOTITE dental implants that were discolored due to contact with residual machine fluid.