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U.S. Department of Health and Human Services

Class 2 Device Recall ELEOS BOWED CANAL FILLING STEMS

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 Class 2 Device Recall ELEOS BOWED CANAL FILLING STEMSsee related information
Date Initiated by FirmJuly 11, 2025
Date PostedAugust 25, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2425-2025
Recall Event ID 97343
510(K)NumberK161520 K203588 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
ProductELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.
Code Information Model No. KSP17100E, KSP17140E, KSP18100E, KSP18140E, KSP20100E, KSP20140E, KSP22100E; UDI: B278KSP17100E0, B278KSP17140E0, B278KSP18100E0, B278KSP18140E0, B278KSP20100E0, B278KSP20140E0, B278KSP22100E0; Lot No. All lots released prior to 2025-07-11.
Recalling Firm/
Manufacturer		 Onkos Surgical, Inc.
77 E Halsey Rd
Parsippany NJ 07054-3714
For Additional Information ContactMatt Dufner
267-566-4560
Manufacturer Reason
for Recall		Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn 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 mdufner@onkossurgical.com. 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 mdufner@onkossurgical.com. 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 mdufner@onkossurgical.com.
Quantity in Commerce554 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JDI
510(K)s with Product Code = JDI
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