Wright Medical Recalls Swanson Great Toe Implants Due to Sterility Documentation
Wright Medical Technology is recalling 30 Swanson Great Toe implants because the firm discovered a lack of adequate documentation confirming sterility.
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 documentation issue regarding sterility confirmation. Per the rubric, this aligns with a Moderate severity (score 2) as it is a voluntary precautionary recall without reported injuries or illnesses.
Plain-English summary
Wright Medical Technology, Inc. is recalling 30 units of the SWANSON GREAT TOE, TITANIUM SZ 4 implant (Part Number 4833104, Lot Number 1558414). The recall was initiated after the firm discovered a lack of adequate documentation confirming sterility on certain products.
The affected implants were distributed in the US and internationally, including Norway, Italy, Germany, France, South Africa, the UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, and Spain. The source text does not specify the number of patients affected or report any illnesses or injuries.
Consumers and healthcare providers should contact Wright Medical Technology, Inc. for further instructions regarding the return or replacement of these specific units.
The recalled product
- Product
- SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104
- Manufacturer
- Wright Medical Technology, Inc.
- Affected units
- 30
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)
- Lot Number 1558414
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 12 recalled by Wright Medical Technology, Inc. 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.
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