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U.S. Department of Health and Human Services

Class 2 Device Recall INBONE

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  Class 2 Device Recall INBONE see related information
Date Initiated by Firm November 04, 2021
Create Date December 01, 2021
Recall Status1 Terminated 3 on January 06, 2023
Recall Number Z-0315-2022
Recall Event ID 89007
510(K)Number K100886  
Product Classification Prosthesis, ankle, semi-constrained, cemented, metal/polymer - Product Code HSN
Product INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
Code Information Model 220222210E, Lot Code 05113580751661825 (GTIN: 00840420124968)
Recalling Firm/
Manufacturer		 Wright Medical Technology Inc
11576 Memphis Arlington Rd
Arlington TN 38002-9497
For Additional Information Contact Meghan Wells
901-867-9971
Manufacturer Reason
for Recall		 The package contents and package labeling do not match.
FDA Determined
Cause 2		 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 in Commerce 0 (2 Quarantined)
Distribution US Nationwide distribution in the states of MI and PA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HSN and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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