Zimmer Recalls Dynesys Set Screws Due to Labeling Discrepancies
Zimmer, Inc. is correcting patient labels for Dynesys Set Screws 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 and involves a labeling discrepancy where the source text explicitly states the product label information is correct, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Zimmer, Inc. is initiating a correction for 58 units of Dynesys Set screw M6 manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland. The recall affects products with REF Numbers 01.03710.006 and 01.03711.006, specifically Lot 2381797 and 2429082.
The company initiated this correction after receiving 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.
These products were distributed nationwide. Healthcare providers and patients should verify the specific reference and lot numbers of their devices against the recall information to determine if they are affected.
The recalled product
- Product
- Dynesys¿ Set screw M6
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 58
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 (2)
- REF Numbers: 01.03710.006 and 01.03711.006 Lot 2381797
- 2429082
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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