Wright Medical Recalls Evans Opening Wedge Plates Due to Sterility Documentation
Wright Medical Technology is recalling 30 units of Evans Opening Wedge Plates because documentation confirming sterility was inadequate.
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 without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Wright Medical Technology, Inc. is recalling 30 units of the EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010. The recall was initiated because the firm discovered a lack of adequate documentation confirming the sterility of these specific products.
The affected products are identified by Lot Number 1556150. These medical devices were distributed in the United States and in several international locations, including Norway, Italy, Germany, France, South Africa, the UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, and Spain.
Healthcare providers and patients should contact Wright Medical Technology for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- 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 1556150
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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