DT MedTech, LLC: Medical Device Recall in 2018 - (Recall #: Z-0402-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.

Product Classification:

Class II

Date Initiated: September 25, 2018

Date Posted: November 14, 2018

Recall Number: Z-0402-2019

Event ID: 81293

Reason for Recall:

Incorrect package labeling identifying the device

Status: Terminated

Product Quantity: 54 units

Code Information:

Lot: AAADP

Distribution Pattern:

Australia, Ireland, Korea, Germany

Voluntary or Mandated:

Voluntary: Firm initiated