Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0234-2013·Announced 2012-11-14

Zimmer Recalls 18 CLS Stem Implants Due to Labeling Discrepancies

Zimmer Inc. is correcting patient labels for 18 CLS Stem implants 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: 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 labeling discrepancy. This aligns with the rubric for 'Minor labeling errors' or 'voluntary precautionary recalls' where the physical product is not defective, resulting in a Moderate severity score.

Plain-English summary

Zimmer Inc. is initiating a correction for 18 units of the CLS Stem medical device. These products were manufactured before March 2010 at the Zimmer GmbH production site in Winterthur, Switzerland, and were distributed nationwide.

The recall was initiated after the company received four complaints regarding a discrepancy between the product patient labels and the product labels. Specifically, the complaints noted inconsistencies 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 units are identified by REF Numbers 29.00.09.137, 29.00.09.162, 29.00.39.070, and 29.00.39.125, and Lot Numbers 2397894, 2393484, 2480480, and 2439729. Consumers and healthcare providers should verify the reference and lot numbers of their CLS Stem implants against this list to determine if they are affected.

The recalled product

Product: CLS Stem
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
Affected units: 18

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 (7)

REF Numbers: 29.00.09.137
29.00.09.162
29.00.39.070
and 29.00.39.125 Lot 2397894
2393484
2480480
2439729

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 →

Same manufacturer · Zimmer, Inc.

See all →

High
Zimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
High
Zimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
FDA (Devices) · 2026-07-01
High
Zimmer Shoulder Reamer Guide System Recalled for Plastic Breakage
FDA (Devices) · 2026-07-01
Moderate
Persona Revision Trabecular Metal Femoral Distal Augment recalled for packaging defect
FDA (Devices) · 2026-07-01
High
Zimmer Off-Axis Comprehensive Shoulder System Reamer Guide Recall
FDA (Devices) · 2026-07-01

Same hazard · mis labeling