The Recall Desk
ModerateFDA (Devices)·Z-0882-2020·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 inner packaging cap may open or fail to separate, potentially delaying 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 hazard is limited to a packaging defect that causes surgical delay rather than direct physical injury or contamination. No injuries or illnesses have been reported, fitting the criteria for a moderate severity rating involving low-risk issues or voluntary precautionary measures.

Plain-English summary

Synthes, Inc. is recalling 25 units of 2.4mm Ti VA Locking Screw Stardrive 18mm Sterile, Part Number 04.210.118TS. The affected products are identified by Lot Numbers 6L20592 and 6L37832. These sterile screws are packaged in a tube system designed to deliver single, sterile screws to the sterile field.

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, the screw may not be removable or usable, which could cause a delay in the surgical procedure. The inner tube is intended to remain closed and retained in the outer cap when presented to the sterile field.

The affected products were distributed nationwide in the United States, specifically in the states of Alabama and Idaho. No injuries or illnesses have been reported in connection with this recall. Healthcare facilities should stop using the affected lots and contact Synthes, Inc. for instructions on returning the products.

The recalled product

Product
2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - 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 (2)

  • Lot Number: 6L20592
  • 6L37832

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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