FDA-Device2023-06-07Class II
LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13
Linkbio Corp.
Hazard
Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).
Sold states
US Nationwide Distribution - AL, GA, IL, IN, LA, NV, TX
Affected count
11 units
Manufactured in
101 Round Hill Dr Ste 7, N/A, Rockaway, NJ, United States
Products
LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1674-2023Don't want to check this manually?
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