Male-Female Midsection components from ELEOS Segmental Limb Salvage System
Onkos Surgical is recalling Male-Female Midsection components used in the ELEOS Segmental Limb Salvage System due to potential for breach of Tyvek seals. The recall affects 99 units distributed across 18 states.
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: This is an FDA Class II recall of a medical device with a potential sterility/seal-integrity issue. No hospitalization or injury has been reported in the source text, and the hazard is stated as a potential risk rather than confirmed harm, placing this at the Moderate level per the rubric.
Plain-English summary
Onkos Surgical, Inc. is recalling Male-Female Midsection components in seven sizes (40mm, 50mm, 60mm, 70mm, 90mm, 110mm, and 140mm) that are part of the ELEOS Segmental Limb Salvage System. These components were shipped to consignees in the following states: Georgia, Texas, Washington, Louisiana, New Jersey, Florida, Arizona, Maryland, Mississippi, Kansas, Illinois, Wisconsin, Kentucky, Pennsylvania, North Carolina, Nebraska, Ohio, and Hawaii.
The recall was initiated due to a potential for breach of Tyvek seals on the affected components. A breach of these seals could compromise the sterile barrier of the product.
Patients and healthcare providers who have these components should contact Onkos Surgical, Inc. for further instructions. The manufacturer has provided specific lot numbers and model numbers to help identify affected units.
The recalled product
- Product
- Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d.…
- Manufacturer
- Onkos Surgical, Inc.
- Affected units
- 99
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 (20)
- a. Model Number: 25001040E
- UDI-DI: B27825001040E0
- Lot Numbers: 1802695
- 1813688
- 1823008
- 1833874
- 1841365
- 1844552
- 1855654
- 1855799
- 1856873
- 1856874
- 1860075
- 1860076
- 1880172
- 1880173
- 1880174
- 1880175
- 1880176
- 1880177
Distribution
Part of a larger recall action
This product is one of 6 recalled by Onkos Surgical, 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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