Z-0315-2022 Class II Terminated
FDA device recall Z-0315-2022 was initiated by Wright Medical Technology Inc on November 4, 2021 and is designated Class II. Reason for recall: The package contents and package labeling do not match. The recall status is terminated (terminated January 6, 2023). Affected quantity: 0 (2 Quarantined).
Recall Details
- Product Type
- Devices
- Report Date
- December 8, 2021
- Initiation Date
- November 4, 2021
- Termination Date
- January 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 0 (2 Quarantined)
Product Description
INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
Reason for Recall
The package contents and package labeling do not match.
Distribution Pattern
US Nationwide distribution in the states of MI and PA.
Code Information
Model 220222210E, Lot Code 05113580751661825 (GTIN: 00840420124968)