FDA (Devices) recall action 68310
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.
Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.
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.
Biomet is recalling G7 Acetabular System Positioning Guide Rods because they may fracture during surgery, potentially causing retained fragments or surgical delays.
Biomet is recalling G7 Acetabular System Positioning Guide Posts because the guide rod may fracture during surgery, potentially causing a delay in the procedure.