FDA-Device2015-10-14Class II
Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates
Synthes (USA) Products LLC
Hazard
Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120.002, 03.120.004 and 03.120.005) for the 4.5 mm LCP Proximal Tibia Plates are not able to be secured to the subsequent versions of these devices as intended.
Sold states
Nationally
Affected count
172
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0024-2016Don't want to check this manually?
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