FDA Medical Device Recalls (openFDA)
DT MedTech, LLC: DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.
- Recall number
- Z-0403-2019
- Recalling firm
- DT MedTech, LLC
- Product
- DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.
- Status
- Terminated
- Initiated
- 2018-09-25
- Posted
- not on file
- Terminated
- 2019-12-05
- Reason
- Incorrect package labeling identifying the device
- Root cause
- Packaging process control
- Action
- DT Med Tech LLC initially notified accounts by email notification on 9/25/18 followed by notification letter; The letters explain the process for the identification and return to HealthLink BV (distribution warehouse in The Netherlands) of the products affected (lot AAADP/AAAEM).
- Quantity
- 1
- Distribution
- Australia, Ireland, Korea, Germany
- Lot, serial or model codes
- Lot: AAAEM
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NTG
- Firm FEI
- 3012104767
- Firm city
- Towson
- Firm state
- MD
- 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