medical Class II Updated 2023-12-27

Exactech, Inc. recalls Exactech Truliant Knee System, Catalog Numbers: a) 02-012

Recalled Product

Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-35-3511, h) 02-022-35-4511, i) 02-022-44-3512, j) 02-022-47-2509, k) 02-022-51-4519

Hazard / Issue

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

Issued by

FDA

Affected States: NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR
Lot/Code Info: a) 02-012-35-3509, GTIN 10885862304346, Serial Numbers: A730624, A730626, A730628, A730630, A730631, A730632, A730633; b) 02-022-35-1509, GTIN 10885862303974, Serial Numbers: A641578, A683756, A683757, A683758, A683759; c) 02-022-35-1513, GTIN 10885862304018, Serial Numbers: A662293; d) 02-022-35-3010, GTIN 10885862304261, Serial Numbers: A662100, A662102, A662104, A662105, A662106, A662107, A662109; e) 02-022-35-3509, GTIN 10885862304346, Serial Numbers: A652047, A652048, A652050, A652052, A652053, A652054, A730952, A730960, A730961; f) 02-022-35-3510, GTIN 10885862304353, Serial Numbers: A662121; g) 02-022-35-3511, GTIN 10885862304360, Serial Numbers: A662301, A662304, A662305; h) 02-022-35-4511, GTIN 10885862304544, Serial Numbers: A684499; i) 02-022-44-3512, GTIN 10885862305206, Serial Numbers: A641603, A641606, A641608, A641612; j) 02-022-47-2509, GTIN 10885862306326, Serial Numbers: A658478, A658486, A702263, A702265, A702267, A702268, A702269, A702271; k) 02-022-51-4519, GTIN 10885862307866, Serial Numbers: A737101, A737106, A737107;
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