FDA (Devices) recall action 77004
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.
Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
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 Equinoxe Narrow Modular Reverse Pilot-Tip Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.
Exactech is recalling the Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer to update instructions for use, clarifying proper reaming technique to prevent instrument breakage.
Exactech is recalling Equinoxe Glenoid Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.
Exactech is recalling 382 Equinoxe Reverse Starter Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.
Exactech is recalling Equinoxe Modular Reverse Pilot-Tip Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.
Exactech is recalling 928 Equinoxe Modular Reverse Pilot-Tip Starter Reamers to update instructions for use. The update clarifies proper reaming technique to prevent instrument breakage.