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 141 rHead Recon Stem Implants because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 310 units of the rHead Recon Stem Implant, Size 4, because the revision rate is higher than other 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 128 Radial Head Assembly Size #2 implants because literature reviews indicate higher revision rates 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 546 sterile bipolar radial head implants 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 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 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 387 units of the #4 Bipolar stem implant from the Stryker rHead system because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 33 rHead Standard Extended Stem implants because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 162 units of rHead Radial Implants because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 45 rHead Standard Extended Stem implants because literature suggests 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 158 Radio Capitellum Large, Right orthopedic implants because literature reviews indicate a higher revision rate than other similar devices.
Howmedica Osteonics Corp. is recalling 750 radial stem implants because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 256 radial stem implants because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 169 Stryker rHead Bipolar stem implants due to a higher-than-expected revision rate and potential performance issues.
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 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 124 Radio Capitellum, Recon Head, Size #4 orthopedic implants because the revision rate is higher than other similar 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 19 rHead Recon Extended Stem implants due to a higher-than-expected revision rate.
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.