Implants & Prosthetics

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.

Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Manufacturing nonconformities are in some lots of the Tube Securement Device, such as the top film layer may be partially or completely missing and some devices may exhibit the appearance of an incorrect shape due to excess material not being removed from the product liner.

Product incorrectly labelled.

The stent-graft inside the delivery system was the incorrect size.

DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.

Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.

Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System, Traction Boot II, due to the boots being assembled incorrectly. The locking ridge on the front face of the boot key socket is facing upwards, which prevents the socket mechanism on the traction boot from attaching properly to the spar of the traction system. This will cause the boot to detach from the traction system.

There is a potential for sterile package breach.

There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins and the inner diameter of the TMINI array guide holes. As a result, the array guide has the possibility of binding to the array fixation pins during drilling.

Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.