FDA-Device2023-07-12Class II
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11
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).
Sold states
US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.
Affected count
20 units
Manufactured in
Oststr. 4-10, N/A, Norderstedt, N/A, Germany
Products
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2066-2023Don't want to check this manually?
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