Orthopedic Implant Stems Recalled for Potential Sterile Seal Failures
Onkos Surgical is recalling 147 orthopedic implant stem components due to potential breaches in their sterile seals. The affected devices were distributed to healthcare facilities in 18 U.S. 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: This recall involves an FDA Class II medical device with potential for compromised sterile seals. No illnesses or injuries have been reported. Per the rubric, theoretical hazards in Class II recalls without reported harm constitute a High severity (Score 3).
Plain-English summary
Onkos Surgical, Inc. is recalling 147 units of segmental stem orthopedic implants for the ELEOS Limb Salvage System due to the potential for breaches in sterile seals. These devices are used in limb preservation surgeries. A compromise to the sterile seal could allow bacterial contamination of the implant device.
The affected products include model numbers CS-09100-03M, CS-10100-03M, CS-11120-03M, CS-13120-03M, CS-15120-03M, and CS-17120-03M with specific associated lot numbers. The devices were shipped from the manufacturer's distribution facility in Olive Branch, Mississippi to consignees in 18 U.S. states: Georgia, Texas, Washington, Louisiana, New Jersey, Florida, Arizona, Maryland, Mississippi, Kansas, Illinois, Wisconsin, Kentucky, Pennsylvania, North Carolina, Nebraska, Ohio, and Hawaii.
Patients and healthcare providers with these implants or inventory should contact Onkos Surgical for guidance. The FDA classifies this as a Class II recall.
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.
- Hazard
- sterile-seal-breach
- contamination-risk
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
Distributed in 18 states:
- AZ
- FL
- GA
- HI
- IL
- KS
- KY
- LA
- MD
- MS
- NC
- NE
- NJ
- OH
- PA
- TX
- WA
- WI
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03