Ethos Collar Stem Orthopedic Implants Recalled for Sterility Seal Breach
Onkos Surgical is recalling 233 Ethos Collar Stem implants due to potential breaches in sterility-assurance seals. The affected units were distributed across 18 states and could contaminate orthopedic implants if the seals are compromised.
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: FDA Class II recall for potential Tyvek seal breaches on surgical orthopedic implants. No illnesses or injuries have been reported. The breach is described as 'potential' rather than confirmed, making this a risk-of-harm situation with no reported harm. Per the severity rubric, theoretical hazards without reported injuries are capped at High (Score 3).
Plain-English summary
Onkos Surgical, Inc. is recalling 233 units of the Ethos Collar Stem, a surgical implant component used in limb-salvage procedures. The product is sold in six model numbers (HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M) across multiple lot numbers.
The recall was initiated because of a potential breach in the Tyvek seals that keep the implant sterile. If these seals are broken, bacteria could contaminate the implant before surgery, creating an infection risk when the device is implanted into the patient.
The affected implants were shipped to healthcare providers in 18 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 who may have these devices should contact Onkos Surgical for specific lot numbers to check against the recall list. Do not use any recalled implants. If you have already received one of these implants, discuss your options with your healthcare provider.
The recalled product
- Product
- Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
- Manufacturer
- Onkos Surgical, Inc.
- Hazard
- seal-breach
- infection-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: HC-09100-03M
- UDI-DI: 278HC0910003M0
- Lot Numbers: 1880652
- 1880653
- 1880654
- 1880655
- 1880656
- 1880657
- 1880658
- 1880659
- 1880660
- 1880661
- 1880662
- 1880663
- 1880664
- 1880665
- 1880666
- 1880667
- 1880668
- 1880669
Distribution
Distributed in 18 states:
- AZ
- FL
- GA
- HI
- IL
- KS
- KY
- LA
- MD
- MS
- NC
- NE
- NJ
- OH
- PA
- TX
- WA
- WI
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