Orthopedic Implant Components Recalled Due to Potential Tyvek Seal Defects
Onkos Surgical is recalling 120 units of Segmental Stem components for the ELEOS LIMB SALVAGE SYSTEM due to potential breaches in Tyvek sterile packaging seals that could compromise product sterility.
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 of an orthopedic implant component with potential sterility compromise. The source text reports no illnesses, injuries, or deaths. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a score of 3.
Plain-English summary
Onkos Surgical, Inc. is recalling 120 units of Segmental Stem components (model numbers FS-11120-03M through FS-21120-03M) used as part of the ELEOS LIMB SALVAGE SYSTEM, an orthopedic surgical device intended for limb salvage procedures.
The recalled components have potential for breach of Tyvek seals, which serve as the sterile barrier protecting the medical device from contamination during storage and transport.
The affected products were distributed from Onkos' facility in Olive Branch, Mississippi to hospitals and surgical centers in 18 states: Georgia, Texas, Washington, Louisiana, New Jersey, Florida, Arizona, Maryland, Mississippi, Kansas, Illinois, Wisconsin, Kentucky, Pennsylvania, North Carolina, Nebraska, Ohio, and Hawaii.
Hospitals and surgical facilities that received these devices should contact Onkos Surgical for instructions regarding the recalled lots and model numbers. No illnesses or injuries related to this defect have been reported to date.
The recalled product
- Product
- Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM
- Manufacturer
- Onkos Surgical, Inc.
- Hazard
- sterility-compromise
- seal-defect
- 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: FS-11120-03M
- UDI-DI: B278FS1112003M0
- Lot Numbers: 1880532
- 1880533
- 1880534
- 1880535
- 1880536
- 1880537
- 1880538
- 1880539
- 1880540
- 1880541
- 1880542
- 1880543. b. Model Number: FS-12120-03M
- UDI-DI: B278FS1212003M0
- Lot Numbers: 1880544
- 1880545
- 1880546
- 1880547
- 1880548
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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