FDA (Devices) recall action 82332
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.
Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.
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 809 units of RingLoc Hip System Self-Tapping Bone Screws due to a potential packaging error where 30mm screws may be labeled as 20mm and vice versa.
Zimmer Biomet is recalling 809 units of RingLoc Hip System Self-Tapping Bone Screws because 30mm screws may have been packaged as 20mm screws, and vice versa.