Onkos Surgical Recalls Mislabelled Limb Salvage System Segmental Stem
Onkos Surgical, Inc. 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 labeling error regarding device dimensions. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall involving minor labeling errors or low-risk issues.
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 2500SP22E). The recall is limited to Lot 1699599.
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 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 should verify the lot number and collar size specifications of any implanted or stored devices against the recall notice. If a device matches the recalled description, it should be removed from use and returned to the manufacturer or reported to the FDA.
The recalled product
- Product
- ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP22E
- 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 1699599
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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