FDA (Devices) recall action 81072
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.
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
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 Biomet is recalling 23,726 RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The device is used to re-attach bone flaps after craniotomy.
Zimmer Biomet is recalling 6,180 units of the RapidFlap SpinDown Clamp because the nut was assembled incorrectly. The device is used to re-attach bone flaps after craniotomy.
Zimmer Biomet is recalling 3,246 RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The device is used to re-attach bone flaps after craniotomy.
Zimmer Biomet is recalling 11,580 RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The devices are used to re-attach bone flaps after craniotomy.
Zimmer Biomet is recalling 12,825 units of the RapidFlap System 12mm SpinDown Clamp because the nut was assembled incorrectly. The defect affects sterile clamps used for craniotomy bone flap re-attachment.
Zimmer Biomet is recalling RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The defect affects 11,736 units distributed worldwide.