Zimmer Recalls BioloX Option Ceramic Femoral Heads Due to Labeling Discrepancies
Zimmer Inc. is correcting patient labels for BioloX Option Ceramic Femoral Head 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: 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 hazard is administrative rather than a direct physical defect causing harm.
Plain-English summary
Zimmer Inc. is initiating a correction to the patient labels of BioloX Option Ceramic Femoral Head System Rx, sterile products. This action involves 88 units manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland. The affected products 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 differences in the reference and lot numbers printed on the labels. The source text states that while the information printed on the product label is correct, the discrepancy was identified in the labeling process.
The affected products are identified by the following REF Numbers: 00-8777-028-02, 00-8777-036-01, 00-8777-036-02, and 00-8777-040-01. Consumers and healthcare providers should verify the reference numbers of their devices against this list. No specific consumer action instructions beyond the correction of labels are detailed in the provided source text.
The recalled product
- Product
- Biolox¿ Option Ceramic Femoral Head System Rx, sterile
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 88
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: 00-8777-028-02
- 00-8777-036-01
- 00-8777-036-02
- and 00-8777-040-01.
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.
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