Recall Z-1880-2025— Onkos Surgical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Onkos Surgical, Inc., initiated 2023-09-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM. Reason: Potential for breach of Tyvek seals..
- Recalling firm
- Onkos Surgical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-01
- Firm location
- Parsippany, NJ, United States
Product description
Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, CB-13152-03M, CB-15152-03M, CB-17152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
Reason for recall
Potential for breach of Tyvek seals.
Data sourced from openFDA. This site is unofficial and independent of the FDA.