The Recall Desk
ModerateFDA (Devices)·Z-0883-2020·Announced 2020-02-05

Synthes 2.4mm Sterile Locking Screw Recall Due to Packaging Defect

Synthes is recalling 25 units of 2.4mm sterile locking screws because the inner packaging cap may open prematurely, potentially preventing the screw from being used during surgery.

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 source text explicitly states the hazard is a potential surgical delay rather than a direct health 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 24mm Sterile (Part Number 04.210.124TS). The recall involves Lot Number 6L37876, which was distributed nationwide in the states of Alabama and Idaho.

The recall is due to a packaging defect where the inner cap may open when the outer cap is removed, or the entire inner tube may remain inside the outer tube. In either case, this could prevent the screw from being removed and used, potentially 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 have 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 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.
Manufacturer
Synthes, Inc.
Category
Medical Device — Orthopedic Implant
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: 6L37876

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 →

Related recalls

Same manufacturer · Synthes, Inc.

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Same hazard · packaging defect

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