FDA-Device2019-11-06Class II
Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
Synthes (USA) Products LLC
Hazard
The subject product measures 4.0mm in diameter instead of 3.5mm.
Sold states
Distributed to NJ.
Affected count
6
Manufactured in
1301 Goshen Pkwy, West Chester, PA, United States
Products
Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0223-2020Don't want to check this manually?
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