Ethos Collar Stem components recalled for potential Tyvek seal breach
Onkos Surgical is recalling Ethos Collar Stem components used in limb salvage systems due to potential breach of Tyvek seals. The recall affects 233 units distributed across multiple U.S. 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 with a potential sterility/seal breach issue. The source text states only a potential hazard with no reported illnesses or injuries, making it a precautionary recall. Per the rubric, this warrants a Moderate severity score.
Plain-English summary
Onkos Surgical, Inc. is recalling Ethos Collar Stem, Cemented, Fluted, 100MM components (Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M), which are components of the ELEOS SEGMENTAL LIMB SALVAGE SYSTEM. A total of 233 units have been recalled due to potential for breach of Tyvek seals.
The recalled product was distributed from Onkos' facility in Olive Branch, Mississippi 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.
Patients who have received this product should consult with their healthcare provider or surgeon. Healthcare providers with questions or concerns should contact Onkos Surgical, Inc. Detailed lot numbers and model numbers are available from the FDA to identify affected units.
The recalled product
- Product
- Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
- Manufacturer
- Onkos Surgical, Inc.
- Affected units
- 233
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: HC-09100-03M
- UDI-DI: 278HC0910003M0
- Lot Numbers: 1880652
- 1880653
- 1880654
- 1880655
- 1880656
- 1880657
- 1880658
- 1880659
- 1880660
- 1880661
- 1880662
- 1880663
- 1880664
- 1880665
- 1880666
- 1880667
- 1880668
- 1880669
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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