Exactech, Inc.: Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013

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) 02-012-47-3011, GTIN 10885862174352, Serial Numbers: A676497; b) 02-012-47-5009, GTIN 10885862174543, Serial Numbers: A641353; c) 02-012-47-5011, GTIN 10885862174550, Serial Numbers: A641341; d) 02-012-65-3013, GTIN 10885862613400, Serial Numbers: A655561

UPC codes

10885862174352, 10885862174543, 10885862174550, 10885862613400

Source

Official record: FDA (Device enforcement) ↗

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