FDA (Devices) recall action 70736
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.
Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
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.
In2Bones is recalling 15 DUAFIT interphalangeal implants because dimensional non-conformity prevents them from fitting into their dedicated holders.
In2Bones is recalling 35 units of DUAFIT PIP 0o CA Size 2 interphalangeal implants because dimensional non-conformity prevents them from fitting into the dedicated holder.