FDAFDA · Food and drugs·Recall number Z-0316-2022
INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
Published December 8, 2021 · Recall initiated: November 4, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The package contents and package labeling do not match.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Wright Medical Technology Inc
- Distributor
- US Nationwide distribution in the states of MI and PA.
- Lot
- Model 220223214E, Lot Code 06113718691661809 (GTIN: 00840420125033)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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