FDA (Devices) recall action 79315
The FDA (Devices) publishes a recall like this one as 70 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 70 pages.
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-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.
Howmedica Osteonics Corp. is recalling 211 Stryker rHead Radial Implants because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 285 rHead Stem Implant Plasma Coated, Size 2 units because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics is recalling 280 Stryker rHead Radial Stem Implants because literature reviews show higher revision rates than similar devices.
Howmedica Osteonics Corp. is recalling 544 radial stem implants because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 546 sterile bipolar radial head implants because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 201 units of the rHead Radial Implant 6 mm Collar, Size 1, because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 170 Lat Assembly Rad Stem Implants because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 305 units of the rHead Stem Implant 6mm Collar, Size 3, because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 121 Radio Capitellum Small, Right orthopedic implants because literature reviews indicate a higher revision rate than expected.
Howmedica Osteonics Corp. is recalling 690 Lateral Assembly, Radial Head Implant, Size 3 units because literature indicates a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 607 Stryker rHead Radial Head implants because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 225 Radio Capitellum, Recon Head, Size #3 orthopedic implants because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 90 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 265 rHead Recon Stem Implant 6mm Collar, Size 1 units because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 283 Stryker rHead Radial Head implants because literature suggests a higher revision rate than similar devices.
Howmedica Osteonics Corp. is recalling 245 rHead Stem Implant 6mm Collar units because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 320 rHead Stem Implant Plasma Coated, Size 3 units because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 107 Radial Head Assy Size #4 implants because literature review indicates higher revision rates than other devices.
Howmedica Osteonics Corp. is recalling 256 units of the rHead Stem Implant 6mm Collar, Size 4, because the revision rate is higher than other similar devices.
Howmedica Osteonics Corp. is recalling 673 units of #3 Bipolar stem implants used in the Stryker rHead system due to a higher-than-expected revision rate.
Howmedica Osteonics Corp. is recalling 230 Lat Assembly Rad Stem Implants because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 170 Radio Capitellum Large, Left orthopedic implants because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 301 rHead Stem Implant Plasma Coated, Size 4 units because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 175 Lat Assembly Rad Stem Implants because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 298 units of the rHead Recon Stem Implant 6mm Collar, Size 3, because literature reviews indicate a higher revision rate than other similar devices.