Recalls / —

—#190255

Product

INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS

FDA product code

HSN — Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K100886

Affected lot / code info

Model 220223214E, Lot Code 06113718691661809 (GTIN: 00840420125033)

Why it was recalled

The package contents and package labeling do not match.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm

Wright Medical Technology Inc

Address

11576 Memphis Arlington Rd, Arlington, Tennessee 38002-9497

Distribution

Distribution pattern

US Nationwide distribution in the states of MI and PA.

Timeline

Recall initiated

2021-11-04

Terminated

2023-01-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #190255. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.