A U.S. launch of the product is expected in just a few weeks.
The agency granted its first approval order under the humanitarian device exemption in spinal pediatrics in the last 15 years.
Most recently with Medtronic, Bryan C. Hanson has more than 20 years of experience in the medical device industry.
After the abrupt announcement, the search is on for a permanent successor.
FDA has categorized the recall as Class I due to the seriousness of the device issue.
The shoulder replacement is used on patients with rotator cuff tears.
The deal will further cement the company’s competitive advantage in providing ‘comprehensive musculoskeletal healthcare’.