Shoulder Prosthesis, Reverse Configuration

Brand Name: Veritas Standard Reverse Total Shoulder

Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.

Short Monobloc Stem Broaches, Size/REF:

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.

Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Brand Name: Reverse Shoulder Prosthesis (RSP)

Knee and Humeral socket implants contain incorrect labeling.

Brand Name: Equinoxe Ergo

Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.

Brand Name: Equinoxe Ergo

Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.