INBONE recallZ-0315-2022 · Wright Medical Technology Inc · initiated Nov 4, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Wright Medical Technology Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The package contents and package labeling do not match.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0315-2022
- Status
- Terminated
- Initiated by the company
- Nov 4, 2021
- Recalling firm
- Wright Medical Technology Inc
- Quantity
- 0 (2 Quarantined)
- Product code
- HSN
- FDA submissions
- K100886
- Distribution
- US Nationwide distribution in the states of MI and PA.
Product description
INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
Code information (models, lots, serial numbers)
Model 220222210E, Lot Code 05113580751661825 (GTIN: 00840420124968)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- INBONE 220222210EWright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall3 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 89007).
- Z-0316-2022 · TerminatedINBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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