FDA Medical Device Recalls (openFDA)
Wright Medical Technology Inc: INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
- Recall number
- Z-0316-2022
- Recalling firm
- Wright Medical Technology Inc
- Product
- INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
- Status
- Terminated
- Initiated
- 2021-11-04
- Posted
- not on file
- Terminated
- 2023-01-06
- Reason
- The package contents and package labeling do not match.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the states of MI and PA.
- Lot, serial or model codes
- Model 220223214E, Lot Code 06113718691661809 (GTIN: 00840420125033)
- 510(k) numbers
- ["K100886"]
- PMA numbers
- not on file
- Product code
- HSN
- Firm FEI
- 1043534
- Firm city
- Arlington
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28