Recall Z-0315-2022
Wright Medical Technology Inc · initiated November 4, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
Codes / lots: Model 220222210E, Lot Code 05113580751661825 (GTIN: 00840420124968)
Reason for recall
The package contents and package labeling do not match.
FDA-determined cause: Nonconforming Material/Component
Action taken
Affected consignees were notified via email and/or Federal Express mail. Consignees are asked to immediately quarantine all recalled products on hand and return all affected product to Wright Medical Arlington TN Warehouse as soon as possible. If the consignee has further distributed the affected product, they are asked to notify the applicable parties at once about this recall. The consignee may copy and distribute the notification letter and Wright Medical will work directly with them to collect the recalled items.
Details
- Recall number
- Z-0315-2022
- Initiated
- November 4, 2021
- Terminated
- January 6, 2023
- Product code
- HSN – Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- Quantity
- 0 (2 Quarantined)
- Distribution
- US Nationwide distribution in the states of MI and PA.
- Recalling firm
- Wright Medical Technology Inc, Arlington, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0316-2022 Class II | INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUSThe package contents and package labeling do not match. | 11/04/2021Terminated |