Segmental Stem Components Recalled for Potential Tyvek Seal Breach
Onkos Surgical is recalling Segmental Stem components of the ELEOS Limb Salvage System due to potential breach of Tyvek seals. The defect could compromise sterility.
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 no reported illnesses or injuries. The hazard—potential Tyvek seal breach compromising sterility—is a quality/contamination risk but is precautionary in nature with no documented adverse health consequences cited in the source text.
Plain-English summary
Onkos Surgical, Inc. is recalling Segmental Stem, Cemented, Bowed, 152MM components (Model Numbers CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M) that are part of the ELEOS Limb Salvage System. A total of 49 units have been affected.
The recall is due to a potential breach of Tyvek seals on the affected devices. This defect could compromise the sterility of the product.
The recalled devices were distributed from Onkos' facility in Olive Branch, MS 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. Specific lot numbers affected include 1880259–1880274 for Model CB-11152-03M; 1880275–1880284 for Model CB-13152-03M; 1880285–1880296 for Model CB-15152-03M; and 1880297–1880307 for Model CB-17152-03M.
Healthcare facilities and patients who have received or implanted these devices should contact Onkos Surgical, Inc. for instructions on return or replacement. Consult with your healthcare provider if you have questions about your individual situation.
The recalled product
- Product
- Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
- Manufacturer
- Onkos Surgical, Inc.
- Affected units
- 49
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: CB-11152-03M
- UDI-DI: B278CB1115203M0
- Lot Numbers: 1880259
- 1880260
- 1880261
- 1880262
- 1880263
- 1880264
- 1880265
- 1880266
- 1880267
- 1880268
- 1880269
- 1880270
- 1880271
- 1880272
- 1880273
- 1880274. b. Model Number: CB-13152-03M
- UDI-DI: B278CB1315203M0
- Lot Numbers: 1880275
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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