Medacta Usa Recalls

Hazard: Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may increase the risk of fracture in the medial region of the proximal humerus.

Hazard: There is a potential for breakage of the small screw used to affix the anti-backout plate.

Hazard: There is a potential for breakage of the small screw used to affix the anti-backout plate.

Hazard: There is a potential for breakage of the small screw used to affix the anti-backout plate.

Hazard: There is a potential for breakage of the small screw used to affix the anti-backout plate.

Hazard: There is a potential for breakage of the small screw used to affix the anti-backout plate.

Hazard: There is a potential for breakage of the small screw used to affix the anti-backout plate.

Hazard: A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of suitable patient conditions prior to placement of the NextAR Shoulder Target Holder: WARNING Target fixation requires adequate coracoid bone stability. Osteoporosis, weakness of the coracoid process, or other deficiencies, could lead to adverse events including bone fracture. Verify that the coracoid bone and relevant patient conditions are suitable before proceeding.

Hazard: A Size 2 trial baseplate was assembled with Size 1 instrument sets.

Hazard: Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis.

Hazard: Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem.

Hazard: Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%. For this reason, we stress the importance of using the 3.5 Nm torque limiting driver if the screw is used, as directed in our surgical techniques.

Hazard: One lot of product does not include a screw for attachment to the tibial base plate.

Hazard: Damaged packaging, lack of sterility assurance

Hazard: Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.

Hazard: The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery.

Hazard: Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.

Hazard: Medacta USA is recalling Versafitcup Impacting Ring because the impaction ring may not fit properly in the implant shell in all cases. This could result in surgical delay potentially increasing possible complications under anesthesia, having to ream up to a larger shell size leaving less bone than planned and repositiong/removal of the shell after initial impaction.

Hazard: The tip of the Quadra Trial Broach size 0, broke during a surgery.

Hazard: Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potential of the rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches.