Segmental Stem Bowed 152MM components recall potential seal breach
Onkos Surgical is recalling Segmental Stem, Canal Filling, Bowed 152MM components of the ELEOS Limb Salvage System due to potential breach of Tyvek seals. The defect could compromise the sterility of the device.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is a potential sterility compromise from seal breach, which is a quality/defect concern rather than a direct safety hazard with documented harm.
Plain-English summary
Onkos Surgical, Inc. is recalling Segmental Stem, Canal Filling, Bowed 152MM components (Model Numbers FB-11152-03M through FB-21152-03M) that are part of the ELEOS Limb Salvage System. A total of 77 units were affected.
The recall is due to a potential for breach of Tyvek seals, which are used to maintain sterility of the device. A compromised seal could affect the sterility assurance of the product.
The affected product was distributed from Onkos' location in Olive Branch, Mississippi to consignees in Georgia, Texas, Washington, Louisiana, New Jersey, Florida, Arizona, Maryland, Mississippi, Kansas, Illinois, Wisconsin, Kentucky, Pennsylvania, North Carolina, Nebraska, Ohio, and Hawaii.
Consignees and customers who have received affected units should contact Onkos Surgical, Inc. for instructions on return or replacement of the recalled devices.
The recalled product
- Product
- Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
- Manufacturer
- Onkos Surgical, Inc.
- Affected units
- 77
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: FB-11152-03M
- UDI-DI: B278FB1115203M0
- Lot Numbers: 1880455
- 1880456
- 1880457
- 1880458
- 1880459
- 1880460
- 1880461
- 1880462
- 1880463. b. Model Number: FB-12152-03M
- UDI-DI: B278FB1215203M0
- Lot Numbers: 1880464
- 1880465
- 1880466
- 1880467
- 1880468
- 1880469. c. Model Number: FB-13152-03M
- UDI-DI: B278FB1315203M0
- Lot Numbers: 1880470
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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