FDA (Devices) recall action 74084
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
Potential for polystyrene particulate presence.
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.
Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices are used for internal bone fixation in the ankle and foot.
Arthrex, Inc. is recalling BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices are used for internal bone fixation in the ankle and foot.
Arthrex, Inc. is recalling BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate.
Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices were distributed in 15 states.
Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices were distributed in 15 states.
Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to a potential for polystyrene particulate presence.