FDA (Devices) recall action 81293
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.
Incorrect package labeling identifying the device
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.
DT MedTech is recalling 54 units of Hintermann Series H3 Poly Inlays because the package labeling incorrectly identifies the device.
DT MedTech is recalling specific talar implants for ankle joints because the package labels incorrectly identify the device.