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 537 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 656 Optetrak Constrained Condylar Offset Screws due to a design incompatibility with certain tibial inserts and trays.
Exactech is recalling 953 Optetrak Constrained Condylar Offset Screws because they are design-incompatible with certain tibial inserts and trays.
Exactech is recalling 606 Optetrak Constrained Condylar Offset Screws because they are incompatible with certain tibial inserts and trays.
Exactech is recalling 643 Optetrak Constrained Condylar Offset Screws because they are incompatible with certain tibial inserts and trays.
Exactech, Inc. is recalling 306 Optetrak Offset Tibial Trays and Screws because a design incompatibility exists between certain screw sizes and tibial inserts.
Exactech, Inc. is recalling 411 Optetrak Constrained Condylar Offset Screws due to a design incompatibility with certain tibial inserts and trays.
Exactech is recalling 547 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.
Exactech, Inc. is recalling 640 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.
Exactech is recalling 678 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain tibial inserts.
Exactech is recalling 889 Optetrak Constrained Condylar Offset Screws because they are incompatible with certain tibial inserts and trays.
Exactech is recalling 665 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 733 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.
Exactech is recalling 920 Optetrak Constrained Condylar Offset Screws because they are incompatible with certain tibial inserts and trays.
Exactech is recalling 537 Optetrak Constrained Condylar Offset Screws due to a design incompatibility with certain tibial inserts and trays.
Exactech is recalling 207 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 720 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 311 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.
Exactech, Inc. is recalling 575 Optetrak Constrained Condylar Offset Screws due to a design incompatibility with certain tibial inserts and trays.
Exactech is recalling 333 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.
Exactech is recalling 683 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.
Exactech is recalling 198 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 527 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.
Exactech is recalling 57 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 109 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.