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U.S. Department of Health and Human Services

Class 2 Device Recall Evolve Proline Radial Head System

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  Class 2 Device Recall Evolve Proline Radial Head System see related information
Date Initiated by Firm August 26, 2020
Create Date September 21, 2020
Recall Status1 Terminated 3 on April 27, 2021
Recall Number Z-2989-2020
Recall Event ID 86278
510(K)Number K991915  K060731  
Product Classification Prosthesis, elbow, hemi-, radial, polymer - Product Code KWI
Product EVOLVE STEM 8.5MM
Model # 496S085
Code Information Lot # 1668777
Recalling Firm/
Manufacturer		 Wright Medical Technology Inc
11576 Memphis Arlington Rd
Arlington TN 38002-9497
For Additional Information Contact Mr. Kevin C Smith
901-867-9971
Manufacturer Reason
for Recall		 Lack of sterility assurance
FDA Determined
Cause 2		 Process control
Action Wright initiated a recall on 08/26/2020. It states the following: 1. Immediately cease all use and distribution of this affected lot 2. Immediately quarantine all recalled products you have found, and return all affected product to Wright Medical as soon as possible. 3. Contact Customer Service at 800-238-7117 for return instructions and replacement inventory. 4. If you have further distributed the affected product, please notify the applicable parties . You may copy and distribute this letter and Wright Medical will work directly with them to collect the recalled items. 5. Wright asks you to complete, sign, and return the form as soon as possible. Please return the completed acknowledgement to Wright Medical via email to: Memphis.FieldAction@wright.com within five (5) working days of this notice. If you have further questions, or are aware of any patient issues with these lots, please do not hesitate to contact Customer Service at Wright Medical at 800-238-7117 for more information.
Quantity in Commerce 16 stems
Distribution USA states: CA, CO, FL, GA, MA, MO, OH, PA, TX OUS: Australia, Canada, Chile, Israel, Spain
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 = KWI and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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