The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0881-2020·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 cap may open or the tube may remain in the outer cap, preventing screw removal.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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. The hazard is a packaging defect that may cause surgical delays but does not involve direct patient injury, infection, or death, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Synthes, Inc. is recalling 25 units of 2.4mm Ti VA Locking Screw Stardrive 16mm Sterile (Part Number 04.210.116TS). The affected lots are 6L20591 and 6L37063. These products were distributed in the United States, specifically in the states of Alabama and Idaho.

The recall is due to a packaging defect where the inner cap could open when the outer cap is removed, or the entire inner tube may remain in 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 how to return the affected units.

The recalled product

Product
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.
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 (2)

  • Lot Number: 6L20591
  • 6L37063

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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