Wright Medical Recalls EVOLVE Modular Radial Heads Due to Sizing Errors
Wright Medical Technology is recalling two lots of EVOLVE Modular Radial Heads because the product size in the package may be incorrect. Both labels and laser markings are wrong.
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. The hazard is a labeling and marking error regarding product size, which is a significant quality issue but does not explicitly report injuries or deaths in the source text, fitting the Moderate category for labeling errors.
Plain-English summary
Wright Medical Technology, Inc. is recalling two lots of EVOLVE Modular Radial Heads. The recall is due to a potential error where the product size inside the package does not match the intended size.
The affected devices are the WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222. The specific lot code is 1633303. The quantity involved is 48 devices. The distribution pattern is listed as US.
The source text states that both the label and the laser marking on the affected product are incorrect. This discrepancy could lead to the use of an incorrectly sized medical device. Healthcare providers should verify the size of the device against the surgical plan before use.
The recalled product
- Product
- WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222
- Manufacturer
- Wright Medical Technology, Inc.
- Affected units
- 48
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 1633303
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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