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Waldemar Link GmbH & Co. KG (Mfg Site) recalls LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and re
Recalled July 12, 2023 · FDA recall Z-2067-2023 · Waldemar Link GmbH & Co. KG (Mfg Site)
Hazard
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation). · FDA Class II
Units
20 units
Sold at
US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.
Description
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
Product
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/21
Manufacturer(s)
Waldemar Link GmbH & Co. KG (Mfg Site)
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →