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U.S. Department of Health and Human Services

Class 2 Device Recall CHARLOTTE Lisfranc

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  Class 2 Device Recall CHARLOTTE Lisfranc see related information
Date Initiated by Firm December 03, 2021
Create Date December 20, 2021
Recall Status1 Open3, Classified
Recall Number Z-0401-2022
Recall Event ID 89086
510(K)Number K141417  
Product Classification Plate, fixation, bone - Product Code HRS
Product Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.
Code Information Lot numbers 02010697711582590 and 02010697711582591, GTIN 00840420108340.
Recalling Firm/
Manufacturer		 Wright Medical Technology, Inc.
1023 Cherry Rd
Memphis TN 38117-5423
For Additional Information Contact Ms. Meghan Wells
901-201-9298
Manufacturer Reason
for Recall		 Incorrect product is contained in the packaging.
FDA Determined
Cause 2		 Under Investigation by firm
Action The recalling firm issued a recall letter dated 03 Dec 2021 on 12/3/2021 via Fed Ex Priority Overnight. The letter explained the packages contain the incorrect screws, provides potential risks and the actions needed to be taken. The consignee is to immediately check their inventory to locate the packaged product and remove them from their point of use. The enclosed business reply form was to be returned via email to confirm receipt of the letter and document product segregation. After the firm receives the reply form, the consignee will be contacted to arrange for return and replacement. The consignee was given the choice of providing subdistribution contact details to the recalling firm so the recalling firm could inform them of the recall, or the consignee can notify their downstream customers of the recall.
Quantity in Commerce 22 units
Distribution Worldwide distribution - US Nationwide distribution in the states of AZ, IA, and SC. The countries of Australia, Canada, Chile, Spain, 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 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 = WRIGHT MEDICAL TECHNOLOGY, INC.
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