Wright Medical Recalls EVOLVE Modular Radial Head Due to Sizing Errors
Wright Medical Technology is recalling 39 EVOLVE Modular Radial Heads because the product size inside the package does not match the label or laser marking.
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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling and marking error regarding product size, which is a significant quality control issue but does not involve a known pathogen or immediate structural failure leading to severe injury.
Plain-English summary
Wright Medical Technology, Inc. is recalling 39 units of the WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm (REF 496H220). The recall involves two lots of the EVOLVE Modular Radial Head where the product inside the package may be the wrong size.
The recall was initiated because both the label and the laser marking on the affected products are incorrect. This discrepancy could lead to the use of an improperly sized medical device during a procedure.
The affected devices were distributed in the United States. Healthcare providers and patients should check their inventory and records for the specific reference number 496H220 and Lot Code 1633010. If the device is found, it should be removed from use and returned to the manufacturer or distributor in accordance with their instructions.
The recalled product
- Product
- WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
- Manufacturer
- Wright Medical Technology, Inc.
- Affected units
- 39
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 Code 1633010
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 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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