FDA (Devices) recall action 78111
The FDA (Devices) publishes a recall like this one as 34 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 34 pages.
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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.
Exactech is recalling 317 Optetrak Offset Tibial Trays because a design incompatibility exists with certain offset spine stiffener screws and constrained condylar tibial inserts.
Exactech is recalling 386 Optetrak Constrained Condylar Offset Screws due to a design incompatibility with certain tibial inserts and trays.
Exactech is recalling 573 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.
Exactech is recalling 893 Optetrak Offset Tibial Trays and Screws because of a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.
Exactech, Inc. is recalling 520 Optetrak Constrained Condylar Offset Screws due to a design incompatibility with certain tibial inserts and trays.
Exactech is recalling 801 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.
Exactech, Inc. is recalling 840 Optetrak Constrained Condylar Offset Screws because of a design incompatibility with certain tibial inserts and trays.
Exactech, Inc. is recalling 114 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.
Exactech is recalling 895 Optetrak Constrained Condylar Offset Screws because they are incompatible with certain tibial inserts and trays.