Onkos Surgical Recalls Mislabelled Limb Salvage System Segmental Stems
Onkos Surgical is recalling four units of the Eleos Limb Salvage System Segmental Stem due to incorrect collar size labeling.
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: The recall is classified as FDA Class II, and the hazard is a minor labeling error regarding dimensions without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Onkos Surgical, Inc. is recalling four units of the Eleos Limb Salvage System Segmental Stem, Canal Filling, Diameter 20mm, Length 120mm, Style Straight, Type Canal Filling, Collar 25mm (Ref 2500SP20E). The recall involves Lot 1700559.
The recall was initiated because the device collar size was incorrectly labeled as 25 mm, whereas it should have been recorded as 32 mm. This labeling error could potentially lead to the use of an incorrectly sized component during medical procedures.
The affected units were distributed to facilities in Arizona, Illinois, and Kansas. Healthcare providers and patients who may have received or used these specific units should contact Onkos Surgical for further instructions on how to proceed.
The recalled product
- Product
- ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E
- Manufacturer
- Onkos Surgical, Inc.
- Hazard
- Affected units
- 4
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 (1)
- LOT 1700559
Distribution
Part of a larger recall action
This product is one of 3 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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