FDA (Devices) recall action 68819
The FDA (Devices) publishes a recall like this one as 8 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 8 pages.
Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
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 47,682 units of 4.0 mm Cancellous Screws because they failed leak tests due to inner cavity damage.
Zimmer, Inc. is recalling 47,682 units of 4.5 mm Malleolar Screws because they failed a leak test due to inner cavity damage.
Zimmer, Inc. is recalling 6.5 mm Cancellous Screws that failed leak tests due to inner cavity damage. The recall covers 47,682 units distributed nationally and internationally.
Zimmer, Inc. is recalling 47,682 units of 6.5 mm Cancellous Screws because they failed a leak test due to damage of the inner cavity.
Zimmer, Inc. is recalling 47,682 units of Magna-Fx Cannulated Bone Screws because they failed leak tests due to inner cavity damage.
Zimmer, Inc. is recalling 6.5 mm Cancellous Screws that failed leak tests due to inner cavity damage. The recall covers 47,682 units distributed nationally and internationally.
Zimmer, Inc. is recalling 47,682 units of Magna-Fx Cannulated Bone Screws because they failed a leak test due to damage of the inner cavity.
Zimmer, Inc. is recalling 47,682 units of 6.5 mm Cancellous Trauma Screws because they failed leak tests due to inner cavity damage.