Synthes USA Recalls Norian Drillable Inject Due to Expiration Date Mismatch
Synthes USA is recalling 5 units of Norian Drillable Inject because kit expiration dates do not align with the earliest component expiration dates.
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 describes a labeling/documentation discrepancy regarding expiration dates without reporting any illnesses, injuries, or specific health hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Synthes USA is recalling 5 units of Norian Drillable Inject (Product Number: 07.704.010S, Lot Number: DSE0733). The recall was initiated after the contract supplier notified DePuy Synthes on June 16, 2017, that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit.
The issue involves some kit expiration dates being later than the earliest expiration date of the component lots, meaning the expiration dates of some components are earlier than that listed on the kit. The product was distributed nationwide.
No specific instructions for consumers are provided in the source text beyond the identification of the affected product and lot.
The recalled product
- Product
- Norian Drillable Inject
- Manufacturer
- Synthes USA
- Hazard
- Affected units
- 5
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 (1)
- Product Number: 07.704.010S Lot Number: DSE0733
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Synthes USA 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.
See all 2 products in this recall →Related recalls
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See all →- ModerateSynthes USA Recalls Norian Drillable Inject Due to Expiration Date Mismatch
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