FDA Enforcement
Class II
Terminated
DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
Recall: Z-0402-2019
·
Reported November 14, 2018
Enforcement
- Recall Number
- Z-0402-2019
- Event ID
- 81293
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- DT MedTech, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- November 14, 2018
- Initiation Date
- September 25, 2018
- Classification Date
- November 7, 2018
- Termination Date
- December 5, 2019
- Address
- 110 West Rd Ste 227, Towson, MD, 21204-2341, United States
Description
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
Code Info
Lot: AAADP
Distribution
Australia, Ireland, Korea, Germany
Quantity
54 units