FDA-Device2018-08-29Class II
CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
In2bones USA, LLC
Hazard
CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates.
Sold states
Worldwide Distribution - US Nationwide and the countries of France
Affected count
47 units
Manufactured in
Attn: Tommy Turpin, 6060 Poplar Ave Ste 380, Memphis, TN, United States
Products
CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2879-2018Don't want to check this manually?
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