The Recall Desk
ModerateFDA (Devices)·Z-1880-2025·Announced 2025-06-04

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.

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: 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.
Category
Medical Device — Orthopedic / Limb Salvage
Hazard
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

Distributed in 18 states:

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.

See all 6 products in this recall →

Related recalls

Same manufacturer · Onkos Surgical, Inc.

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Same hazard · sterility compromise

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