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FDA Announces Zimmer Biomet Recall For Comprehensive Reverse Shoulder Replacement

InjuredGo.com Personal Injury Law Firm Can Help With Zimmer Biomet Recall

According to a recent FDA Alert, Zimmer Biomet is recalling the Comprehensive Reverse Shoulder because these devices are fracturing at a higher rate than is stated in the labeling. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.

The Comprehensive Reverse Shoulder is a shoulder replacement device that is surgically implanted to help restore arm movement. This device is beneficial for patients with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and previously failed shoulder joint replacement.

Contact injuredGo.com Personal Injury Law Firm for more details.  Read more HERE.

Device Use

The Comprehensive Reverse Shoulder is a shoulder replacement device that is surgically implanted to help restore arm movement. This device is beneficial for patients with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and previously failed shoulder joint replacement.

Recalled Product:

  • Product Description: Comprehensive Reverse Shoulder System Humeral Tray Model 115340
  • Trade Name: Biomet Comprehensive Reverse Shoulder Humeral
  • Product Code: KWS, PAO
  • Lot Numbers: All lots with part number 115340; See full list of lot numbers
  • Distribution Dates: October, 2008 to September, 2015
  • Manufacturing Dates: August 25, 2008 to September 27, 2011
  • Devices Recalled: 3662

On December 20, 2016 Zimmer Biomet sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement form to all affected customers. The notice asked customers to:

  • Review the safety notice and ensure appropriate staff is aware of the notice.
  • Identify and quarantine any affected devices in stock.
  • The Zimmer Biomet sales representative will remove the affected device from the facility.
  • Complete and return the Certificate of Acknowledgement form within 3 days via email to corporateequality.postmarket@zimmerbiomet.com.
  • Retain a copy of the Certificate of Acknowledgement form for records in the event of a compliance audit.

The notice also stated that there are no specific patient monitoring instructions related to this recall that are recommended beyond existing surgical follow up protocol.

Contact injuredGo.com Personal Injury Law Firm for more details.  Read more HERE.

Comprehensive Reverse Shoulder System is a registered trademark of Zimmer Biomet.