The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2820-2015·Announced 2015-10-07

Zimmer Recalls Guide Wires Due to Incorrect Expiration Date Labeling

Zimmer, Inc. is recalling 112,568 sterile guide wires because the labels state a 10-year expiration date, while testing supports only 5 years.

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 and involves a labeling error regarding expiration dates. There are no reported illnesses or injuries, and the hazard is theoretical, fitting the criteria for a moderate severity score.

Plain-English summary

Zimmer, Inc. is recalling 112,568 units of Zimmer Guide Wires used for orthopedic procedures. The recall is due to a labeling discrepancy where the external carton and patient record labels state a 10-year expiration date, but package testing supports a 5-year expiration date for these specific guide wires.

The affected products include various diameters and lengths of smooth, bullet tip, and ball tip guide wires. All non-expired, distributed lots with the 10-year expiration date on the label are included in this recall. The products were distributed worldwide, including the United States (nationwide, Puerto Rico, and Virgin Islands) and numerous international countries.

Healthcare providers and consumers should stop using these guide wires and contact Zimmer, Inc. for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

The recalled product

Product
Zimmer Guide Wires for orthopedic procedures.
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Instruments
Hazard
Affected units
112,568

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 (9)

  • 00-2228-024-00 2.4MM Diameter Bullet Tip Guide Wire
  • 00-2255-025-00 Humeral Smooth Guide Wire 2.4mm 70cm Length
  • 00-2255-026-00 Humeral Bullet Tip Guide Wire 2.4mm Diameter 70cm Length
  • 47-2237-033-00 Smooth Guide Wire 2.4mm Diameter 100cm Length
  • 47-2237-037-00 3.0MM Diameter Smooth Guide Wire 100cm Length
  • 47-2237-038-00 Bullet Tip Guide Wire 3.0mm Diameter 100cm Length
  • 47-2255-008-00 Ball Tip Guide Wire 2.4mm Diameter 70cm Length
  • 47-2255-008-01 Ball Tip Guide Wire 3.0mm Diameter 100cm Length All non-expired
  • distributed lots with a 10 year expiration date on the label.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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