Z-1694-2021 Class II Terminated
FDA device recall Z-1694-2021 was initiated by Signature Orthopedics Pty Limited on April 20, 2021 and is designated Class II. Reason for recall: Product mislabeled, with the incorrect product inside the package. The recall status is terminated (terminated January 19, 2023). Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 9, 2021
- Initiation Date
- April 20, 2021
- Termination Date
- January 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
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 Pattern
US Nationwide distribution in the state of NC.
Code Information
LOT# 71541-1