Exactech, Inc.: Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536

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) 01-030-40-0636, GTIN 10885862549655, Serial Numbers: A678476, A678485, A678486, A678495, A678508, A678516, A678819, A678820, A678822, A678826, A678827, A678832, A678845, A678847, A678855, A678859, A678863; b) 01-030-40-0640, GTIN 10885862549662, Serial Numbers: A746645, A746649; c) 01-030-42-0536, GTIN 10885862549945, Serial Numbers: A655570, A655573, A655574

UPC codes

10885862549655, 10885862549662, 10885862549945

Source

Official record: FDA (Device enforcement) ↗

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