Z-2425-2025 Class II Ongoing
FDA device recall Z-2425-2025 was initiated by Onkos Surgical, Inc. on July 11, 2025 and is designated Class II. Reason for recall: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. The recall status is ongoing. Affected quantity: 554 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 3, 2025
- Initiation Date
- July 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 554 units
Product Description
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
Reason for Recall
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Distribution Pattern
US Nationwide distribution in the states of AK, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, WA & WI.
Code Information
Model No. KSP17100E, KSP17140E, KSP18100E, KSP18140E, KSP20100E, KSP20140E, KSP22100E; UDI: B278KSP17100E0, B278KSP17140E0, B278KSP18100E0, B278KSP18140E0, B278KSP20100E0, B278KSP20140E0, B278KSP22100E0; Lot No. All lots released prior to 2025-07-11.