ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
- Company
- Onkos Surgical, Inc.
- Recall Initiated
- September 22, 2024
- Posted
- May 28, 2025
- Recall Number
- Z-1857-2025
- Quantity
- 24 units
- Firm Location
- Parsippany, NJ
Reason for Recall
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
Distribution
US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.
Lot / Code Info
Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873, 1989874
Root Cause
Nonconforming Material/Component
Action Taken
Onkos Medical notified consignees via email on about 09/22/2024. Consignees were instructed to segregate and quarantine any product on hand immediately, complete and return the response form, and arrange for existing implants to be returned.
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