Exactech Novation Hip System, Catalog Numbers: 134-36-45

Reason: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

Code information: GTIN 10885862024046, Serial Numbers: A763009, A763010, A763011, A763017, A763018, A763020

Distribution pattern: US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK