Segmental Stem Components for ELEOS Limb Salvage System Recalled
Onkos Surgical is recalling segmental stem components of the ELEOS Limb Salvage System due to potential for breach of Tyvek seals. The affected components were distributed across multiple states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this as Class II. The source text states a "potential for breach of Tyvek seals" but explicitly reports no illnesses or injuries. This is a risk-of-harm scenario for a medical device where the hazard is theoretical and no adverse events have been reported; per the rubric, such recalls score at most 3.
Plain-English summary
Onkos Surgical, Inc. is recalling segmental stem components (100MM and 120MM models) that are part of the ELEOS Limb Salvage System. The recall affects 147 units with model numbers CS-09100-03M, CS-10100-03M, CS-11120-03M, CS-13120-03M, CS-15120-03M, and CS-17120-03M across multiple lot numbers.
The recalled components have a potential for breach of Tyvek seals. The product was distributed from Onkos' location in Olive Branch, MS to consignees in the following states: GA, TX, WA, LA, NJ, FL, AZ, MD, MS, KS, IL, WI, KY, PA, NC, NE, OH, and HI.
Healthcare facilities and clinicians who have received affected units should verify lot numbers against the FDA recall notice (Z-1879-2025) and discontinue use of any matching components. Contact Onkos Surgical, Inc. for instructions on device return or replacement.
The recalled product
- Product
- a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM
- Manufacturer
- Onkos Surgical, Inc.
- Affected units
- 147
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: CS-09100-03M
- UDI-DI: B278CS0910003M0
- Lot Numbers: 1880308
- 1880309
- 1880310
- 1880311
- 1880312
- 1880313
- 1880314
- 1880315
- 1880316
- 1880317
- 1880318
- 1880319
- 1880320
- 1880321
- 1880322
- 1880323
- 1880324
- 1880325
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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