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 285 Stryker rHead Radial Head implants because literature reviews indicate a higher revision rate 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 269 rHead Recon Stem Implants because literature reviews indicate 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 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 33 rHead Standard Extended Stem implants because literature reviews indicate a higher revision rate 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 19 rHead Recon Extended Stem implants due to a higher-than-expected revision rate.
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 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 128 Radial Head Assembly Size #2 implants because literature reviews indicate higher revision rates than other similar devices.
Howmedica Osteonics Corp. is recalling 118 rHead Recon Stem Implants 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 166 Radial Head Assy Size #3 orthopedic implants because the revision rate is higher 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 19 rHead Recon Extended Stem Size 3 orthopedic implants due to a higher-than-expected revision rate.
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 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 190 units of Lat Assembly, Rad Stem Implant, Collar 6mm, Size 2. The recall is due to higher revision rates identified in literature.