FDA (Devices) recall action 68216
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.
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.
Biomet, Inc. is recalling 102 EZPass Suture Passers because the nitinol wire may buckle and become kinked, making the instrument difficult to use.
Biomet is recalling 100 units of EZPass Nylon Monofilament Suture Passers because the internal wire may buckle, making the instrument difficult to use.
Biomet is recalling 100 units of EZPass Suture Retriever instruments because the nitinol wire may buckle and become kinked, making the device difficult to use.