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.
|