FDA Medical devices recall ·
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING… recall
- Recall number
- Z-2424-2025
- Date
- (initiated July 11, 2025)
- Company / brand
- Onkos Surgical, Inc.
77 E Halsey Rd, Parsippany, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 15 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
Why was it recalled?
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. 2500CP16E; UDI: B2782500CP16E0; Lot No. All lots released prior to 2025-07-11.
Distribution
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.
States: Alaska Arizona California Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi North Carolina New Jersey New York Ohio Tennessee Texas Utah Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2424-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.