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U.S. Department of Health and Human Services

Class 2 Device Recall 2.8 TriLock Screw

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 Class 2 Device Recall 2.8 TriLock Screwsee related information
Date Initiated by FirmApril 12, 2024
Date PostedMay 14, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1821-2024
Recall Event ID 94445
510(K)NumberK091479 
Product Classification Screw, fixation, bone - Product Code HWC
ProductAPTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
Code Information Part No. A-5850.22/1; UDI-DI: 76300378022PA; Lot No. 24377397.
FEI Number 3009540749
Recalling Firm/
Manufacturer		 Medartis Inc.
1195 Polk Dr
Warsaw IN 46582-8602
For Additional Information ContactCustomer Service
574-241-6531
Manufacturer Reason
for Recall		Screw is 16mm long instead of 22mm long.
FDA Determined
Cause 2		Process control
ActionConsignees were sent an "URGENT: Field Safety Notice" via email and printed letter, dated 4/12/2024, notifying them of this recall event. Consignees are asked to locate and quarantine affected devices, coordinate the return of affected devices to their distributor, inform all users of the device of this recall event, and return the provided Customer Reply form with the relevant information. Customers with any questions can call Medartis at 574-241-6531 between 7:30 AM and 6:30 PM EST, Monday through Friday. Questions can also be sent via email to Complaints.US@Medartis.com.
Quantity in Commerce110 units
DistributionWorldwide - US Nationwide distribution in the state of TX and the countries of Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, & Switzerland.
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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