← FDA ENFORCEMENT
Z-2399-2026Class II
DT MedTech, LLC
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
DT MedTech, LLC
Product type
Device
Status
Ongoing
Report date
2026-06-17
Distribution
Worldwide - US Nationwide distribution in the states of CA, AR, AZ, ID and the countries of PER, KOR.
Firm state
TN
Product quantity
67 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change ControlReason 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.
Product description
Hintermann Series Talar Implant, Left, Size 2 REF 302112
Code / lot info
Lot: AACAA/ DI: B095302112
Other recalls SPEQ maps to Documentation & Change Control
2026-10-21Class IIIn2bones USA, LLC2026-10-21Class IIW L Gore & Associates, Inc.2026-10-21Class IIEthicon, LLC2026-10-21Class IIBoston Scientific Corporation
See all Documentation & Change Control recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →