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U.S. Department of Health and Human Services

Class 2 Device Recall Hintermann Series H3

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 Class 2 Device Recall Hintermann Series H3see related information
Date Initiated by FirmMarch 24, 2026
Date PostedJune 10, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2399-2026
Recall Event ID 98987
PMA NumberP160036 
Product Classification Prosthesis, ankle, uncemented, non-constrained - Product Code NTG
ProductHintermann Series Talar Implant, Left, Size 2 REF 302112
Code Information Lot: AACAA/ DI: B095302112
FEI Number 3012104767
Recalling Firm/
Manufacturer		 DT MedTech, LLC
111 Moffitt St
Mcminnville TN 37110-2235
For Additional Information ContactCustomer Service
1800-521-5002
Manufacturer Reason
for Recall		Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
FDA Determined
Cause 2		Labeling Change Control
ActionOn March 24, 2026, DT MedTech issued a Urgent Medical Device Recall Notification to affected consignees. DT MedTech requested that the firm take the following actions: 1. Return of all available stock of Hintermann Series Talar Implants (Part/REF number 302112, Lot number AACAA) 2. Please provide confirmation that all available stock of the part detailed below has been returned to Vilex LLC at 4516 S 700 E Suite 100A Salt Lake City, Utah 84107 USA. 3. For any questions or concerns, contact Vilex Quality at quality@vilex.com or 800-521-5002.
Quantity in Commerce67 units
DistributionWorldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR.
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.
PMA DatabasePMAs with Product Code = NTG
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