Stryker X-Change Medial Wall Mesh Small Recall for Incorrect Contents
Howmedica Osteonics Corp. is recalling 40 units of Stryker X-Change Medial Wall Mesh Small (6-Petal) because boxes contain the 4-Petal version instead.
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, but the hazard is a labeling/packaging error (wrong product in box) rather than a defect in the implanted device itself, fitting the 'Minor labeling errors' criterion.
Plain-English summary
Howmedica Osteonics Corp. is recalling 40 units of the Stryker X-Change Medial Wall Mesh Small (6-Petal), Part # 0942-8-025. The recall is due to a packaging error where boxes labeled for the 6-Petal mesh contain the 4-Petal X-Change Wall Mesh Small, Part # 0942-8-015, instead.
The affected product is intended to be implanted to replace a hip joint. The specific lot number is G6091225, with an expiration date of 2022-06. The recall number is Z-0514-2020.
The product was distributed to foreign markets, including Australia, France, Finland, Germany, Italy, Japan, New Zealand, the Netherlands, Norway, Romania, Spain, Sweden, and the UK. Healthcare providers should stop using the affected product and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 40
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 Number: G6091225
- Exp. Date: 2022-06 UDIs: (01)04546540167712(17)220618(10)
Distribution
Distribution scope not specified by the agency.
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