Synthes USA Recalls Norian Drillable Inject Due to Expiration Date Mismatch
Synthes USA is recalling 239 units of Norian Drillable Inject because kit expiration dates do not align with the earliest expiration dates of the component lots.
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 discrepancy regarding expiration dates without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving labeling errors or low-risk issues.
Plain-English summary
Synthes USA is recalling 239 units of Norian Drillable Inject, Product Number 07.704.003S, Lot Number DSD9110. The product was distributed nationwide.
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. Specifically, some kit expiration dates were 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.
Healthcare providers and consumers should stop using the affected product and contact Synthes USA for further instructions.
The recalled product
- Product
- Norian Drillable Inject
- Manufacturer
- Synthes USA
- Affected units
- 239
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: 07.704.003S Lot Number: DSD9110
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
Same manufacturer · Synthes USA
See all →- ModerateSynthes USA Recalls Norian Drillable Inject Due to Expiration Date Mismatch
FDA (Devices) · 2018-02-21
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