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U.S. Department of Health and Human Services

Class 2 Device Recall Medartis APTUS

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 Class 2 Device Recall Medartis APTUSsee related information
Date Initiated by FirmApril 24, 2026
Date PostedJune 09, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2361-2026
Recall Event ID 98952
510(K)NumberK202589 
Product Classification Screw, fixation, bone - Product Code HWC
ProductMedartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
Code Information UDI/DI 07630037887706, Lot Numbers: 25444702, 24425542, 24404471, 25441997
FEI Number 3003236702
Recalling Firm/
Manufacturer		 Medartis AG
Hochbergerstrasse 60e
Basel Town Switzerland
For Additional Information ContactMr. Mario Kegler
0041-61-6333797
Manufacturer Reason
for Recall		The cannulation of the CCS screw is not centered.
FDA Determined
Cause 2		Under Investigation by firm
ActionMedartis issued an URGENT: Field Safety Notice - Recall to its consignees on 5/4/2026 via USPS. The notice explained the problem with the device, potential risks associated with its use, intraoperatively and postoperatively, and provided postoperative patient recommendations. Response to the Field Safety Notice should be made to: fieldaction.us@medartis.com or Medartis Inc., 1195 Polk Drive Warsaw, IN 46582. The device are to be returned.
Quantity in Commerce13 units
DistributionUS Nationwide distribution in the states of LA, TX. IN, CA, NC.
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 = HWC
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