FDA Medical Device Recalls (openFDA)
DT MedTech, LLC: Hintermann Series Talar Implant, Left, Size 2 REF 302112
- Recall number
- Z-2399-2026
- Recalling firm
- DT MedTech, LLC
- Product
- Hintermann Series Talar Implant, Left, Size 2 REF 302112
- Status
- Open, Classified
- Initiated
- 2026-03-24
- Posted
- 2026-06-10
- Terminated
- not on file
- Reason
- Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.
- Root cause
- Labeling Change Control
- Action
- On 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
- 67 units
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR.
- Lot, serial or model codes
- Lot: AACAA/ DI: B095302112
- 510(k) numbers
- not on file
- PMA numbers
- ["P160036"]
- Product code
- NTG
- Firm FEI
- 3012104767
- Firm city
- Mcminnville
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28