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U.S. Department of Health and Human Services

Class 2 Device Recall WRIGHT EVOLVE Proline Head

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  Class 2 Device Recall WRIGHT EVOLVE Proline Head see related information
Date Initiated by Firm December 27, 2019
Create Date February 06, 2020
Recall Status1 Terminated 3 on July 23, 2021
Recall Number Z-1102-2020
Recall Event ID 84673
510(K)Number K060731  
Product Classification Prosthesis, elbow, hemi-, radial, polymer - Product Code KWI
Product WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222
Code Information Lot code 1633303
Recalling Firm/
Manufacturer		 Wright Medical Technology, Inc.
1023 Cherry Rd
Memphis TN 38117-5423
Manufacturer Reason
for Recall		 Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.
FDA Determined
Cause 2		 Process control
Action The firm initiated the recall by email and letter on 12/27/2019. The notices requests the following actions: Immediately quarantine all recalled products they have and return all affected product to Wright Medical 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 Wright Medical will work directly with them to collect the recalled items.
Quantity in Commerce 48 devices
Distribution US
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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