ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
Recall
- Recall Number
- Z-2423-2025
- Event Number
- 97343
- Firm
- Onkos Surgical, Inc.
- FEI Number
- 3013450937
- Product Code
- JDI
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- July 11, 2025
- Posted
- August 25, 2025
- Address
- 77 E Halsey Rd, Parsippany, NJ, 07054-3714
Description
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
An email dated 7/11/25 was sent to consignees notifying them of this recall. Distributors and sales personnel are to segregate and quarantine affected devices immediately and return a completed Product and Distribution Information Table to [email protected]. Affected devices are to be returned within two business days to Onkos Surgical. Consignees with any questions are to contact Matt Dufner with any questions at 267-566-4560 or [email protected]. An email dated 8/5/25 was sent to surgical consignees notifying them of this recall. Hospitals are to remove affected devices from their facilities, forwarding any affected devices remaining in their possession to their Onkos Sales Representative. Onkos Surgical is in the process of determining the root cause of this recall issue and is performing additional testing on returning devices. Consignees with any questions are to contact Matt Dufner at 267-566-4560 or [email protected].
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.
30 units