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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

rHead Stem Implant 6mm Collar, Size 4.Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics

Class I - Dangerous

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.

Oct 24, 2017 Implants & Prosthetics Nationwide View Details →

147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3 Gang 1o2¿ Manifold (Blue, Yellow, Red), Check Valve Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical

Class I - Dangerous

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Jul 31, 2017 Surgical Instruments Nationwide View Details →

140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical

Class I - Dangerous

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Jul 31, 2017 Surgical Instruments Nationwide View Details →

Lateral Assembly, Radial Head Implant, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics

Class I - Dangerous

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.

Oct 24, 2017 Implants & Prosthetics Nationwide View Details →

Lopez Valve¿, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical

Class I - Dangerous

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Jul 31, 2017 Surgical Instruments Nationwide View Details →

117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 3 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical

Class I - Dangerous

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Jul 31, 2017 Surgical Instruments Nationwide View Details →

rHead Standard Extended Stem, 6mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics

Class I - Dangerous

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.

Oct 24, 2017 Implants & Prosthetics Nationwide View Details →

rHead Recon Extended Stem Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics

Class I - Dangerous

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.

Oct 24, 2017 Implants & Prosthetics Nationwide View Details →

rHead Recon Stem Implant non-coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics

Class I - Dangerous

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.

Oct 24, 2017 Implants & Prosthetics Nationwide View Details →

126" (320 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-Way Stopcock, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical

Class I - Dangerous

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Jul 31, 2017 Surgical Instruments Nationwide View Details →

#2 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics

Class I - Dangerous

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.

Oct 24, 2017 Implants & Prosthetics Nationwide View Details →

Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed with a polymer liner on the inside diameter for lubricity, stainless steel wire reinforcement within the wall for torque transmission and strength, and polymer materials along the length of the catheter for support and flexibility. The catheter has an atraumatic tip and a hub/strain relief combination for kink resistance (at the hub), device connectivity, and device handling.

Boston Scientific

Class I - Dangerous

Potential polymer material degradation.

Dec 11, 2017 Diagnostic Equipment Nationwide View Details →

Radio Capitellum Large, Left Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics

Class I - Dangerous

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.

Oct 24, 2017 Implants & Prosthetics Nationwide View Details →

Radio Capitellum, Recon Head, Size #2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics

Class I - Dangerous

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.

Oct 24, 2017 Implants & Prosthetics Nationwide View Details →

135" (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical

Class I - Dangerous

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Jul 31, 2017 Surgical Instruments Nationwide View Details →

rHead Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics

Class I - Dangerous

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.

Oct 24, 2017 Implants & Prosthetics Nationwide View Details →

radial head implant #4 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics

Class I - Dangerous

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.

Oct 24, 2017 Implants & Prosthetics Nationwide View Details →

rHead Recon Stem Implant non-coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics

Class I - Dangerous

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.

Oct 24, 2017 Implants & Prosthetics Nationwide View Details →

Lateral Assembly, Radial Head Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics

Class I - Dangerous

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.

Oct 24, 2017 Implants & Prosthetics Nationwide View Details →

rHead Stem Implant 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics

Class I - Dangerous

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.

Oct 24, 2017 Implants & Prosthetics Nationwide View Details →