FDA (Devices) recall action 86896
The FDA (Devices) publishes a recall like this one as 16 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 16 pages.
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
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 specific lots of sterile shoulder system surgical instrument handles because a breach in the packaging seal could lead to loss of sterility.
Biomet is recalling specific lots of Ringloc Acetabular System self-tapping bone screws because a breach in the sterile seal could lead to loss of sterility.
Biomet is recalling specific lots of RapidFire Clips used for craniofacial bone fixation because a breach in the sterile seal could lead to loss of sterility.
Biomet is recalling specific lots of RingLoc+ Quick Connect Drill Bits because a breach in the sterile seal could lead to loss of sterility.
Biomet, Inc. is recalling 7,428 units of Titanium IFS devices (Item 909680) because a breach in the sterile seal could lead to loss of sterility.
Biomet is recalling specific lots of Oxford Fixed Lateral knee implants because a breach in the sterile seal could lead to loss of sterility.
Biomet is recalling specific lots of cannulated screw systems because a breach in the sterile seal could lead to loss of sterility.
Biomet is recalling specific lots of the Comprehensive Reverse Shoulder System because a breach in the sterile seal could lead to loss of sterility.
Biomet is recalling specific lots of RINGLOC BIPOLAR Hip System components due to a potential breach in the sterile seal, which could lead to loss of sterility.
Biomet is recalling specific lots of cannulated screw systems because a breach in the sterile packaging seal could lead to loss of sterility.
Biomet is recalling specific lots of cannulated screw systems because a breach in the sterile seal could lead to loss of sterility.
Biomet is recalling specific lots of Custom Cancellous Thread devices because a breach in the sterile seal could lead to loss of sterility.
Biomet is recalling specific lots of Sterile Trac System Thinflap 24 MM Burr Hole Plates because a breach in the sterile seal could lead to loss of sterility.
Biomet is recalling specific lots of Phoenix interlocking screws because a breach in the sterile seal could lead to loss of sterility.
Biomet is recalling specific lots of OSS Polyethylene Tibial Bushings because a breach in the sterile seal could lead to loss of sterility.
Biomet, Inc. is recalling 7,428 units of the M/H Modular Stem (Item 13-104756) because a breach in the sterile seal could lead to loss of sterility.