Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0228-2013·Announced 2012-11-14

Zimmer Inverse/Reverse Screw System Label Correction

Zimmer, Inc. is correcting patient labels for Inverse/Reverse Screw systems manufactured before March 2010 due to discrepancies in reference and lot numbers.

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: This is a Class II recall involving a labeling discrepancy where the source text explicitly states the product label information is correct, indicating a minor labeling error or documentation issue rather than a direct safety hazard.

Plain-English summary

Zimmer, Inc. is initiating a correction to the patient labels of Zimmer Inverse/Reverse Screw system products. This action affects 45 units distributed nationwide that were manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland.

The recall was initiated after the company received four complaints regarding a discrepancy between the product patient labels and the product labels concerning reference and lot numbers. The source text notes that while the information printed on the product label is correct, the discrepancy was identified in the patient labels.

Consumers and healthcare providers should verify the reference and lot numbers of the affected products against the provided lists. The specific reference numbers involved are 01.04223.018, 01.04223.024, 027, 030, 033, 036, and 042, associated with various lot numbers listed in the recall documentation.

The recalled product

Product: Zimmer Inverse/Reverse Screw system,
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
Affected units: 45

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 (20)

REF Numbers: . 01.04223.018
01.04223.024
027
030
033
036
042 Lot 2398030
2430525
2384923
2390913
2396961
2399397
2416652
2424581
2430509
2449770
2497224
2383780
2430522
2430523

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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