FDA-Device2016-06-15Class II
DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43
Synthes (USA) Products LLC
Hazard
Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. The high growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points. This could potentially be reproduced during use and reprocessing.
Sold states
US nationwide distribution.
Affected count
244 units
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1912-2016Don't want to check this manually?
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