Orthopedic Stereotaxic Instrument

TMINI Femur Tracking Array REF 109003

Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.

Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-164

The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.

Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-164

The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.

Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5

Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)

Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7

Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)

MICS3 Angled Sagittal Saw Attachment;

A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment.

ATEC Lateral Navigation Disc Prep Instruments

Due a design issue where the navigated array connection geometry is incorrect.

ATEC Lateral Navigation Disc Prep Instruments

Due a design issue where the navigated array connection geometry is incorrect.

Mazor X robotic guidance system

Software errors that can result in incorrect surgical instrument positioning during spinal surgery.

Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments:

The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. However, the NorthStar OCT Navigation Instruments are compatible for use with Medtronic s Solera toolcards only.