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FDA Provides Additional News on Recall of Zimmer Biomet Reverse Shoulder Implant

Van O'Steen

February 11, 2017

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Silver Spring, Maryland—The FDA has provided additional information to patients and medical providers regarding the recall of the Comprehensive Reverse Shoulder Implant initiated by Zimmer Biomet on December 20, 2016. The recall has been designated a "Class 1" recall, which reflects the highest classification available to the FDA. Class 1 recalls are reserved for those products where there is a reasonable probability that the use of the device will cause serious adverse health consequences or death.

Recalled Product

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

Distribution Dates

October 2008 to September 2015

Manufacturing Dates

August 25, 2008 to September 27, 2011

Number of Devices Recalled

3,662

If you believe you may have one of the affected devices, you should promptly consult your physician for an evaluation.

You may also be entitled to compensation and should contact an attorney experienced in cases involving defective medical devices to learn about your legal rights.

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