Risks 2016-09-29T22:50:58+00:00

Indications for Use, Contraindications, and Risks

Rotation Medical Bioinductive Implant (Collagen Scaffold)

Indications for Use
The Rotation Medical collagen scaffold is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Contraindications and Risks
The Rotation Medical collagen scaffold is not indicated to replace damaged tendon or reinforce the strength of any tendon repair.

The Rotation Medical collagen scaffold is not indicated for patients with a known history of hypersensitivity to bovine-derived materials. Patient may experience a sensitization reaction.

Rotation Medical Bone Staples

Indications for Use
The Rotation Medical bone staple is indicated for fixation of soft tissue grafts during rotator cuff repair.

Contraindications and Risks
The Rotation Medical bone staples are not indicated to affix soft tissue to bone or to reinforce the strength of any tendon repair.

The Rotation Medical bone staples are not indicated where there is inadequate quality of bone. Patient may experience incomplete healing.

Rotation Medical Tendon Staples

Indications for Use
The Rotation Medical tendon staple is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures, such as the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Contraindications and Risks
The Rotation Medical tendon staples are not indicated to affix soft tissue to adjoining soft tissue or to reinforce the strength of any tendon repair.

The Rotation Medical tendon staples are not indicated where there is inadequate soft tissue support or an irreparable tendon system. Patient may experience incomplete healing.