Zimmer DTO Implant Label Correction for Reference and Lot Number Discrepancies
Zimmer, Inc. is correcting patient labels for DTO 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 documentation discrepancy, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Zimmer, Inc. is initiating a correction to the patient labels of DTO Implants manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland. This action follows the receipt of four complaints regarding discrepancies 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 exists in the labeling documentation. The affected products were distributed nationwide. Specific reference numbers and lot numbers are identified in the recall records.
Consumers and healthcare providers should verify the reference and lot numbers of any implanted devices against the corrected labeling information provided by Zimmer, Inc. to ensure accurate patient records.
The recalled product
- Product
- DTO" Implant
- Manufacturer
- Zimmer, Inc.
- Hazard
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 (10)
- REF Numbers: 01.03791.050
- 01.03791.060
- and 01.03791.080 Lot: 2417930
- 2417948
- 2417950
- 2417956
- 2429074
- 2432771
- 2462074
- 2512965
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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