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U.S. Department of Health and Human Services

Class 2 Device Recall Tibial Opening Wedge Osteotomy Plate, Titanium

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  Class 2 Device Recall Tibial Opening Wedge Osteotomy Plate, Titanium see related information
Date Initiated by Firm March 11, 2021
Create Date April 09, 2021
Recall Status1 Open3, Classified
Recall Number Z-1380-2021
Recall Event ID 87584
510(K)Number K032187  
Product Classification Plate, fixation, bone - Product Code HRS
Product Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.
Code Information Part number: AR-13200T-15.0; Lot code:12135408
Recalling Firm/
Manufacturer
Arthrex, Inc.
1370 Creekside Blvd
Naples FL 34108-1945
Manufacturer Reason
for Recall
It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
FDA Determined
Cause 2
Under Investigation by firm
Action A Recall notification letter titled, "URGENT: RECALL NOTIFCIATION" was sent to consignees on 03/11/2021 via email. The email sent to the consignees requested that the parts be returned. Additionally, the firm is currently awaiting all distributed units to be returned. The recalling firm requested that consignees immediately discontinue use, sale, and distribution of the product. Instructions were provided for Arthrex Agencies (North America), Arthrex Subsidiaries (LATAM and APAC), direct customers (EMEA), and Arthrex Subsidiaries (EMEA) as follows: Arthrex Agencies (North America): Please contact Arthrex Product Surveillance at 866-267-9138 or complaints@arthrex.com. The consignee is not required to notify patients of the product recall. Arthrex Subsidiaries (LATAM and APAC): Please contact Arthrex Product Surveillance at 866-267-9138 or complaints@arthrex.com. The consignee is not required to notify patients of the product recall. Direct customers (EMEA): Please contact Arthrex Product Surveillance at +49 89 90 90 05 5240 or complaints@arthrex.com. The consignee is not required to notify patients of the product recall. Arthrex Subsidiaries (EMEA): Please contact Arthrex Product Surveillance at +49 89 90 90 05 5240 or complaints@arthrex.com. The consignee is not required to notify patients of the product recall.
Quantity in Commerce 32 units
Distribution Worldwide distribution - US Nationwide distribution in the states of GA, LA, CA, FL, OR, TX and the countries of India, Russia, Kingdom of Bahrain, Italy, Canada, Sweden, Poland, Australia, New Zealand, and Mexico.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = ARTHREX, INC.
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