The Recall Desk
ModerateFDA (Devices)·Z-0880-2020·Announced 2020-02-05

Synthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect

Synthes, Inc. is recalling 25 units of 2.4mm sterile locking screws because the packaging may fail to keep the screw sealed, potentially causing surgical delays.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to a packaging defect that causes surgical delays rather than direct patient injury or death, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Synthes, Inc. is recalling 25 units of 2.4mm Ti VA Locking Screw Stardrive 12mm Sterile (Part Number 04.210.112TS). The recall involves Lot Number 6L36824, which was distributed in Alabama and Idaho.

The recall is due to a defect in the sterile tube packaging. There is a possibility that the inner cap could open when the outer cap is removed, or the entire inner tube could remain in the outer tube. In either case, this could prevent the screw from being removed and used, causing a surgical delay. The inner tube is designed to remain closed and retained in the outer cap when presented to the sterile field.

Healthcare facilities that received these products should stop using them and contact Synthes, Inc. for instructions on return or replacement.

The recalled product

Product
2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.
Manufacturer
Synthes, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
25

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: 6L36824

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Synthes, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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