FDA (Devices) recall action 88859
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.
Packaged dental implant contains a different size then the size declared on the labeling.
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 83 dental implants from lot 166300 because the implants differ in size from what is labeled on the packaging. The implants were distributed across multiple US states and Japan.
Implant Direct is recalling 61 dental implants because the packaged implants are a different size than declared on the labeling. Patients who may have received these implants should contact their healthcare provider.