FDA (Devices) recall action 72688
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 firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.
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.
Zimmer, Inc. is recalling 87 Universal Power System handpieces because a malfunction could cause them to start unexpectedly when connected to a power source.
Zimmer, Inc. is recalling 89 Universal Power System handpieces that may start by themselves when the power source is connected.