ELEOS Male-Female Midsection 40MM Orthopedic Component Recall
Onkos Surgical is recalling the ELEOS Male-Female Midsection 40MM component (Part Number 25001040E) of the ELEOS Limb Salvage System due to a potential assembly defect that could affect surgical positioning during implantation.
What this means for you
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 a risk-of-harm orthopedic surgical component where a potential assembly defect could occur intraoperatively. No reported illnesses or injuries are mentioned in the source text, but the defect poses a potential risk during critical surgical procedures.
Plain-English summary
Onkos Surgical, Inc., is recalling the ELEOS Male-Female Midsection 40MM (Part Number 25001040E), a component of the ELEOS Limb Salvage System. The recall was issued by the U.S. Food and Drug Administration.
The product may experience a potential challenge with intraoperative assembly, specifically with the external taper of the midsection mating to the internal taper of a proximal femur component. This could occur during surgical assembly.
The affected product was distributed nationwide to facilities in Arizona, California, Florida, Maryland, Missouri, North Carolina, and Tennessee. Lot Numbers 1989873 and 1989874 are involved. The device is identified by UDI-DI B27825001040E0.
Healthcare providers and facilities that have received this product should contact Onkos Surgical, Inc., for instructions regarding the recalled component. Affected patients should discuss any concerns with their healthcare provider.
The recalled product
- Product
- ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
- Manufacturer
- Onkos Surgical, Inc.
- Affected units
- 24
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)
- Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873
- 1989874
Distribution
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