FDA (Devices) recall action 84067
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.
The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion.
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 is recalling 274 IO Scan Adapters because a loose part could fall into a patient's mouth, posing a risk of aspiration or ingestion.
Implant Direct Sybron Manufacturing is recalling 232 IO Scan Adapters because a loose part could fall into a patient's mouth, causing aspiration or ingestion.