Smith & Nephew Recalls Radial Osteotome Blades Due to Incorrect Expiration Dates
Smith & Nephew is recalling nine Radial Osteotome Blades because the expiration dates on the labels are incorrect. The devices were distributed in the US and Australia.
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 specific defect is a labeling error (incorrect expiration date) with no reported injuries or illnesses, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Smith & Nephew, Inc. is recalling nine units of Radial Osteotome Blade, REF 71369314. These medical devices are used for cutting or preparing bone. The recall is being conducted because the expiration date provided on the label is incorrect.
The affected lot numbers are 14HSY0006R, 15MSY0005R, 15KSY0023R, 09FSY0003R, and 12HSY0040R. The devices were distributed worldwide, specifically to the United States (Tennessee and New Jersey) and Australia.
Healthcare providers and consumers should stop using these specific devices and contact Smith & Nephew for instructions on how to return or dispose of them. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 9
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 (5)
- Lot Numbers: 14HSY0006R
- 15MSY0005R
- 15KSY0023R
- 09FSY0003R
- and 12HSY0040R.
Distribution
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