FDA-Device2014-02-26Class II
Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows.
Synthes, Inc.
Hazard
The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate.
Sold states
USA (nationwide) Distribution.
Affected count
143
Manufactured in
1302 Wrights Ln E, West Chester, PA, United States
Products
Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1057-2014Don't want to check this manually?
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