Onkos Surgical Recalls ELEOS Limb Salvage System Segmental Stem Due to Labeling Error
Onkos Surgical is recalling four units of the ELEOS Limb Salvage System Segmental Stem because the device collar size was incorrectly labeled as 25 mm instead of 32 mm.
What this means for you
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 involves a minor labeling error regarding the device collar size, which fits the criteria for moderate severity involving low-risk issues or voluntary precautionary measures.
Plain-English summary
Onkos Surgical, Inc. is recalling four units of the ELEOS Limb Salvage System Segmental Stem, Canal Filling, Diameter 18mm, Length 120mm, Style Straight, Type Canal Filling, Collar 25mm, Ref 2500SP18E. The recall is due to a labeling error where the device collar size was incorrectly recorded as 25 mm, whereas it should have been recorded as 32 mm.
The affected units are from Lot 1700558. The distribution pattern for these units includes Arizona, Illinois, and Kansas. The agency has classified this recall as Class II.
Consumers and healthcare providers who have purchased or received these specific units should contact Onkos Surgical, Inc. for further instructions on how to return or replace the product.
The recalled product
- Product
- ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E
- 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 1700558
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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