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 605 sterile bipolar radial head implants because literature reviews indicate a higher revision rate than other similar devices.
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 124 Radio Capitellum, Recon Head, Size #4 orthopedic implants because the revision rate is higher than other similar devices.
Howmedica Osteonics Corp. is recalling 163 Radio Capitellum, Recon Head implants because literature reviews indicate a higher revision rate than other similar devices.
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 191 Stryker rHead Radial Head implant assemblies because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 180 sterile-packed radial stem implants 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 999 units of the #3 Bipolar radial head implant because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 543 units of the #2 Bipolar stem implant from the Stryker rHead system due to higher-than-expected revision rates.
Howmedica Osteonics Corp. is recalling 216 rHead Recon Stem Implants because the revision rate is higher than other similar devices, potentially affecting post-surgery performance.
Howmedica Osteonics Corp. is recalling 268 units of the rHead Stem Implant 6mm Collar, Size 2, because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 396 Stryker rHead Radial Stem Implants, Size 2, because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 431 radial stem implants because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 1,213 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 314 rHead Recon Stem 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 81 units of Stryker rHead Radial Head Implant Assemblies because literature indicates higher revision rates than similar devices.
Howmedica Osteonics Corp. is recalling 492 Stryker rHead Radial Stem Implants because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 10 units of the Radio Capitellum Broach Large, Right, due to a higher-than-expected revision rate and potential performance issues.
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 628 sterile radial head implants because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 141 rHead Recon Stem Implants because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 158 Radio Capitellum Large, Right orthopedic implants because literature reviews indicate a higher revision rate than other similar devices.