Stryker SWANSON Finger Joint Implant Incorrect Sizing Label on Carton
Wright Medical Technology is recalling 17 Stryker SWANSON Finger Joint Implants (size 00) due to incorrect sizing labels applied to carton packaging. Devices with lot numbers 1728375 and 1728376 were distributed across multiple US states and internationally.
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 involves a labeling error on medical device packaging with no reported illnesses or injuries. The hazard is informational rather than functional, classified as a minor labeling error per FDA severity rubric.
Plain-English summary
Wright Medical Technology is recalling 17 Stryker SWANSON Flexspan Finger Joint Implants, size 00 (REF 4700020), sterile, due to an incorrect sizing label applied to the carton packaging. The affected lot numbers are 1728375 and 1728376, identified by UDI #00840420121707.
In the United States, the devices were distributed in Arizona, California, Florida, Georgia, New York, Pennsylvania, and Tennessee. Internationally, distribution included Australia, France, the Netherlands, Sweden, and the United Kingdom.
Healthcare providers and patients who have these devices should verify the actual device size matches clinical records and documentation. Any individuals with questions or concerns about this recall should contact Wright Medical Technology or the FDA.
The recalled product
- Product
- Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- Affected units
- 17
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 (2)
- Lot numbers 1728375 and 1728376
- UDI #00840420121707.
Distribution
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