Exactech, Inc.: Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03

Hazard

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

Details from the source

Reason for recall: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. Distribution: 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 Quantity: N/A Lot/code info: a) 350-41-23, GTIN none, Serial Numbers: A658148; b) 350-42-03, GTIN none, Serial Numbers: A688867, A688880, A688864, A688868, A688870, A688872, A688873, A688876, A688879, A688881, A688882

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.