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U.S. Department of Health and Human Services

Class 2 Device Recall Fusion Nail

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 Class 2 Device Recall Fusion Nailsee related information
Date Initiated by FirmNovember 10, 2025
Date PostedDecember 09, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0890-2026
Recall Event ID 97971
510(K)NumberK151008 
Product Classification Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
ProductEndo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
Code Information Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;
Recalling Firm/
Manufacturer		 Waldemar Link GmbH & Co. KG (Mfg Site)
Oststr. 4-10
Norderstedt Germany
For Additional Information ContactJennifer Lubrecht
862-477-0370
Manufacturer Reason
for Recall		The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
FDA Determined
Cause 2		Process control
ActionOn November 10, 2025, URGENT: MEDICAL DEVICE RECALL letters were emailed to distributors. Actions to be taken: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. Please return the product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801 Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions.
Quantity in Commerce18 units
DistributionUS distribution to states of: AL, GA, and TX.
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 = KRO
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