FDA-Device2015-10-21Class II
Inserter for Titanium Elastic Nails (TEN), orthopedic device
Synthes (USA) Products LLC
Hazard
potential for mechanical failures such as breakage.
Sold states
US (nationwide) distribution and one Internationally to Australia.
Affected count
1550
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
Inserter for Titanium Elastic Nails (TEN), orthopedic device
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0125-2016Don't want to check this manually?
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