Exeter V40 Trial Head 26mm -3 Color Mislabeling
An orthopedic trial component may have incorrect color labeling. The Exeter V40 Trial Head (26mm, -3) may appear green when it should be blue. Two units distributed in Ireland.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving color mislabeling on a surgical trial component where incorrect size selection could result from the labeling discrepancy. No illnesses or injuries have been reported, but the potential for harm from surgical sizing error is inherent to the defect.
Plain-English summary
The Exeter V40 Trial Head, 26mm, -3 (catalog number 6364-8-026), manufactured by Howmedica Osteonics Corp., is subject to this recall due to color mislabeling. The product may appear green when it should be blue. In orthopedic surgery, color coding on trial components is used to identify size variants—green normally indicates a 26mm, +3 size, not the 26mm, -3 for which this product is intended. The mislabeling could result in incorrect size selection during surgical procedures.
Two units of the affected product were distributed internationally, specifically to Ireland. The recall involves lot number G7207242 (UDI-DI: 07613327188660).
Healthcare facilities and surgeons who may have this product should verify that their inventory matches the expected blue color for the 26mm, -3 size designation. Any product displaying the incorrect green color should be segregated from inventory and not used. Contact Howmedica Osteonics Corp. or your supplier for instructions regarding return or replacement.
The recalled product
- Product
- Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 2
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)
- UDI-DI: 07613327188660
- Lot Number: G7207242
Distribution
Distribution scope not specified by the agency.
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