FDA recall Z-0883-2020

Synthes, Inc. · Class II · device

Product

2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.

Reason for recall

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.

Distribution

US Nationwide distribution in the states of AL and ID.

Key facts

Status
Terminated
Initiation date
2019-12-16
Report date
2020-02-05
Termination date
2020-06-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
West Chester, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0883-2020