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U.S. Department of Health and Human Services

Class 2 Device Recall Limb Salvage System With BioGrip

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 Class 2 Device Recall Limb Salvage System With BioGripsee related information
Date Initiated by FirmDecember 22, 2023
Date PostedMay 23, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1817-2025
Recall Event ID 96781
510(K)NumberK203815 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
ProductELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
Code Information Model Number: HC-13120-03M. UDI-DI: B278HC1312003M0. Serial Numbers: P230274-1XX (XX represents 23 parts in sequential order from 101-123).
FEI Number 3013450937
Recalling Firm/
Manufacturer		 Onkos Surgical, Inc.
77 E Halsey Rd
Parsippany NJ 07054-3714
For Additional Information ContactSean Curry
201-650-7349
Manufacturer Reason
for Recall		Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
FDA Determined
Cause 2		Labeling Change Control
ActionONKOS Surgical notified their distributors on about 12/22/2023 via email. They were instructed to segregate and quarantine the product immediately, complete and return the "Product and Distribution Information" form within 2 business days and return any existing implants on hand within 2 business days after signing the acknowledgement. They were also instructed that they will receive replacement implants and to place them in their modular segmental collar stem implant packs.
Quantity in Commerce23 units
DistributionUS Nationwide distribution in the states of California, Kentucky, and Wisconsin.
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
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