Hip stems recalled over potential mix of two catalog numbers in packaging
Howmedica Osteonics is recalling 55 Exeter V40 hip stems because packages labeled for one catalog number may contain the other size, and patient labels may also be affected.
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: Scored 2 under the labeling-error criterion: the notice describes a package-to-contents mix-up between two sizes, with no hazard or reported harm stated.
Plain-English summary
Exeter V40 Stem 44MM No 2 (catalog number 0580-1-442) and Exeter V40 Stem 37.5MM No 0 (catalog number 0580-1-352) are being recalled for a potential product mix.
A package labeled as catalog number 0580-1-442, lot A00976, may contain catalog number 0580-1-352, lot G8754849, and vice versa. The recall notice adds that patient labels may also be impacted.
The recall covers 55 units, all distributed outside the United States, in the United Kingdom. The FDA has classified the action as Class II.
The enforcement record describes the packaging mix-up and does not state any injury or patient consequence. Facilities holding the listed lots should verify contents against the package label before use and follow the firm's instructions.
The recalled product
- Product
- 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 55
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 (6)
- 1. Model/Catalog Number: 0580-1-442
- UDI-DI: 04546540153319
- Lot Number: A00976
- 2. Model/Catalog Number: 0580-1-352
- UDI-DI: 04546540153241
- Lot Number: G8754849
Distribution
Distribution scope not specified by the agency.
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