Zimmer Recalls Dynesys Stabilizing Cords Due to Labeling Discrepancies
Zimmer, Inc. is correcting patient labels for Dynesys L.I.S. Stabilizing Cords manufactured before March 2010 due to discrepancies in reference and lot numbers.
What this means for you
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 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 Dynesys L.I.S. Stabilizing Cords, Rx, Sterile. The recall involves 973 units distributed nationwide that were manufactured before March 2010 at the Zimmer GmbH production site in Winterthur, Switzerland.
The action was taken 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.
This recall is classified as Class II by the FDA. Consumers and healthcare providers should verify the reference and lot numbers of the affected units against the provided list to ensure proper identification and documentation.
The recalled product
- Product
- Dynesys¿ L.I.S. Stabilizing cord Rx, Sterile
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 973
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 (16)
- REF Numbers: 01.03711.100 and 01.03711.200 Lot2290106
- 2322753
- 2322757
- 2325303
- 2328500
- 2350135
- 2363929
- 2363972
- 2366663
- 2377045
- 2391793
- 2409738
- 2422397
- 2444114
- 2448948
- 2453742
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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