2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Steril...
FDA Recall #Z-0883-2020 — Class II — December 16, 2019
Product Description
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.
Recalling Firm
Synthes, Inc. — West Chester, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
25 total
Distribution
US Nationwide distribution in the states of AL and ID.
Code Information
Lot Number: 6L37876
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated