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 269 rHead Recon Stem 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 544 radial stem implants because literature reviews indicate higher revision rates 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 303 rHead Recon Stem Implant Plasma Coated, Size 2 units because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 214 Radio Capitellum Small, Left orthopedic implants because literature reviews indicate higher revision rates than 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 396 rHead Recon Stem Implant Plasma Coated, Size 3 units because literature reviews indicate a higher revision rate than other similar devices.
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 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 66 units of rHead Standard Extended Stem implants due to higher-than-expected revision rates.
Howmedica Osteonics Corp. is recalling 286 units of the rHead Radial Implant 6 mm Collar, Size 4, because literature reviews indicate a higher revision rate 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 81 units of Stryker rHead Radial Head Implant Assemblies because literature indicates higher revision rates than similar devices.
Howmedica Osteonics Corp. is recalling 270 rHead Stem Implant Plasma Coated, Size 1 units because literature indicates a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 133 rHead Recon Stem Implants because the revision rate is higher than other similar devices, potentially affecting post-surgery performance.
Howmedica Osteonics Corp. is recalling 605 sterile bipolar radial head implants because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 150 Stryker rHead Radial Head implants because literature reviews indicate a higher revision rate 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 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 283 Stryker rHead Radial Head implants because literature suggests a higher revision rate than similar devices.
Howmedica Osteonics Corp. is recalling 285 Stryker rHead Radial Head implants because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 36 units of rHead Standard Extended Stem implants due to a higher-than-expected revision rate and potential performance issues.
Howmedica Osteonics Corp. is recalling 314 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 19 rHead Recon Extended Stem Size 3 orthopedic implants due to a higher-than-expected revision rate.