FDA-Device2020-02-05Class II
2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
Synthes, Inc.
Hazard
There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.
Sold states
US Nationwide distribution in the states of AL and ID.
Affected count
25 total
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0881-2020Don't want to check this manually?
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