Smith & Nephew Recalls EVOS Screws Due to Incorrect Expiration Dates
Smith & Nephew is recalling 71 units of EVOS Screws because the labels contain multiple or incorrect 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 and involves a labeling error (incorrect expiration dates) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Smith & Nephew, Inc. is recalling 71 units of EVOS Screws. These screws are part of the EVOS MINI plating system and are indicated for fracture fixation, arthrodesis, reconstruction, replantation, or reduction of small bones and small bone fragments.
The recall was initiated because multiple or incorrect expiration dates were provided on the affected designation labels. The affected products were distributed internationally to Denmark, Sweden, France, and Spain.
Healthcare providers and patients should stop using the affected EVOS Screws and contact Smith & Nephew for instructions on how to return the product.
The recalled product
- Product
- EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments.
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 71
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)
- Part Numbers: 72424030
- 72424010
- 72424012
- 72424016
- 72424018
- 72424020
- 72424022
- 72424024
- 72434026
- 72434028
- 72434030
- 72423014
- 72423016
- 72434065
- 72434070
- 72434075
- 72412465
- 72424032
- 72424040
- 72424055
Distribution
Distribution scope not specified by the agency.
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