Zimmer Recalls Tibia Intramedullary Nails Due to Labeling Discrepancies
Zimmer Inc. is correcting patient labels for Sirus intramedullary nails for tibia 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 labeling discrepancies 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 the patient labels of Sirus intramedullary nails for tibia, cannulated. The affected products were manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland. A total of 195 units are involved in this recall, which is distributed nationwide.
The recall was initiated 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 action is a correction to the patient labels. The source text does not specify additional consumer actions beyond the initiation of the correction by the manufacturer.
The recalled product
- Product
- Sirus¿ intramedullary nail for tibia, cannulated ¿
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 195
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 (20)
- REF Numbers: 02.02631.030
- 02.02631.031
- 02.02631.033
- 02.02631.034
- 02.02631.036
- 02.02631.038
- 02.02631.130
- 02.02631.131
- 02.02631.133
- 02.02631.134
- 02.02631.142
- 02.02631.233
- 02.02631.925
- 02.02631.928
- 02.02631.930
- 02.02631.931
- 02.02631.933
- 02.02631.934
- 02.02631.936
- and 02.02631.940. Lot: 2394172
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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