Recall Z-1857-2025— Onkos Surgical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Onkos Surgical, Inc., initiated 2024-09-22. It names one FDA 510(k) clearance: K161520. Product: ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System. Reason: Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur..
- Recalling firm
- Onkos Surgical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-09-22
- Firm location
- Parsippany, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.