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U.S. Department of Health and Human Services

Class 2 Device Recall The Aequalis Ascend Flex Shoulder System

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  Class 2 Device Recall The Aequalis Ascend Flex Shoulder System see related information
Date Initiated by Firm May 28, 2021
Create Date July 12, 2021
Recall Status1 Terminated 3 on April 14, 2023
Recall Number Z-2025-2021
Recall Event ID 88004
510(K)Number K122698  
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
Product Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile
Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
Code Information Item Number DWF500 Lot # 1179AW Exp. Date 2026-02-24 and  Item Number DWF510 Lot # 1197AW Exp. Date 2026-02-25
Recalling Firm/
Manufacturer		 Tornier, Inc
10801 Nesbitt Ave S
Bloomington MN 55437-3109
For Additional Information Contact Meghan Wells
901-201-9298
Manufacturer Reason
for Recall		 Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
FDA Determined
Cause 2		 Employee error
Action Consignees were sent a Tornier "Urgent-Field Safety Notice - Medical Device Recall" letter dated May 28, 2021. The letter was addressed to Healthcare professionals and distributors. The letter described the problem and product involved. Advised consignees to immediately discontinue use of the affected product and to return any unused affected product to their facility. Advised their distributors to notify all accounts. They also attached a questionnaire needed for inventory status.Immediately quarantine all recalled products they have and return all affected product to Tornier SAS as soon as possible. If they have further distributed the affected product, we are asking them to notify the applicable parties at once about this recall. They may copy and distribute the notification letter and Tornier SAS will work directly with them to collect the recalled items. If you have any questions or concerns, please do not hesitate to contact the undersigned or contact Customer Service +1 888 494 7950.
Quantity in Commerce 20
Distribution IL and TX Belgium, France and United Kingdom
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 = KWS and Original Applicant = Tornier SAS
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