Recall Z-0402-2019— DT MedTech, LLC
Class II · Terminated
Class II FDA medical device recall by DT MedTech, LLC, initiated 2018-09-25, terminated 2019-12-05. FDA's recall record names no specific 510(k) clearance for this event. Product: DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.. Reason: Incorrect package labeling identifying the device.
- Recalling firm
- DT MedTech, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-25
- Terminated
- 2019-12-05
- Firm location
- Towson, MD, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.