Synthes, Inc. recalls 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a…

Recall date

December 16, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0881-2020

FDA classification

Class II

Brand / firm

Synthes, Inc.

Sold / distributed

US Nationwide distribution in the states of AL and ID.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.