Z-0402-2019 Class II Terminated
FDA device recall Z-0402-2019 was initiated by DT MedTech, LLC on September 25, 2018 and is designated Class II. Reason for recall: Incorrect package labeling identifying the device The recall status is terminated (terminated December 5, 2019). Affected quantity: 54 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 14, 2018
- Initiation Date
- September 25, 2018
- Termination Date
- December 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54 units
Product Description
DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
Reason for Recall
Incorrect package labeling identifying the device
Distribution Pattern
Australia, Ireland, Korea, Germany
Code Information
Lot: AAADP