Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0235-2013·Announced 2012-11-14

Zimmer Recalls Mueller Low Profile Cups Due to Label Discrepancies

Zimmer Inc. is correcting patient labels for Mueller Low Profile Cups manufactured before March 2010 due to reference and lot number discrepancies.

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, but the source text explicitly states that the information printed on the product label is correct and the issue is a documentation discrepancy. This aligns with the rubric for minor labeling errors or voluntary precautionary recalls where no physical defect or injury is reported.

Plain-English summary

Zimmer Inc. is initiating a correction for the Original M.E. Mueller Low Profile Cup Sterile, Rx. This action affects six units of the product manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland. The affected products were distributed nationwide.

The recall was initiated after Zimmer received four complaints regarding a discrepancy between the product patient labels and the product labels. Specifically, the complaints noted differences in the reference and lot numbers. The source text indicates that while the information printed on the product label is correct, the discrepancy exists in the labeling documentation.

The affected reference numbers are 63.32.46, 63.32.60, and 63.32.62. The affected lot numbers are 2378026, 2468907, and 2370934. Consumers and healthcare providers should verify the reference and lot numbers on their products against this list.

The recalled product

Product: Original M.E. Mueller" Low Profile Cup Sterile, Rx
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
Affected units: 6

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 (4)

REF Numbers: 63.32.46
63.32.60 and 63.32.62.Lot 2378026
2468907
2370934

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 40 recalled by Zimmer, 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 40 products in this recall →

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