Device product
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
Z-2424-2025
Product summary
- Event
- Event 97343
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-2424-2025
Official wording
Reason: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Code information: Model No. 2500CP16E; UDI: B2782500CP16E0; Lot No. All lots released prior to 2025-07-11.
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.
Derived failure modes
-
Unknown
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.