FDA recall Z-1694-2021
Signature Orthopedics Pty Limited · Class II · device
Product
Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.
Reason for recall
Product mislabeled, with the incorrect product inside the package.
Distribution
US Nationwide distribution in the state of NC.
Key facts
- Status
- Terminated
- Initiation date
- 2021-04-20
- Report date
- 2021-06-09
- Termination date
- 2023-01-19
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Lane Cove West, Australia
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1694-2021