Recall Z-0403-2019
DT MedTech, LLC · initiated September 25, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.
Codes / lots: Lot: AAAEM
Reason for recall
Incorrect package labeling identifying the device
FDA-determined cause: Packaging process control
Action taken
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).
Details
- Recall number
- Z-0403-2019
- Initiated
- September 25, 2018
- Terminated
- December 5, 2019
- Product code
- NTG – Prosthesis, Ankle, Uncemented, Non-Constrained
- Quantity
- 1
- Distribution
- Australia, Ireland, Korea, Germany
- Recalling firm
- DT MedTech, LLC, Towson, MD
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0402-2019 Class II | DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components…Incorrect package labeling identifying the device | 09/25/2018Terminated |