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U.S. Department of Health and Human Services

Class 2 Device Recall PROFEMUR

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  Class 2 Device Recall PROFEMUR see related information
Date Initiated by Firm May 04, 2022
Create Date June 02, 2022
Recall Status1 Open3, Classified
Recall Number Z-1225-2022
Recall Event ID 90140
510(K)Number K123434  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
Code Information Catalog Number(s): PHAPCLS7; Lot Number(s): 1903727; Expiration Date: 11/24/2029; UDI/DI Number: 00192629112773
Recalling Firm/
Manufacturer		 MicroPort Orthopedics Inc.
5677 Airline Rd
Arlington TN 38002-9501
For Additional Information Contact
866-872-0211
Manufacturer Reason
for Recall		 One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.
FDA Determined
Cause 2		 Process change control
Action The firm sent out a recall notification to the distributors on 05/04/2022 via email. Phone calls were also made to the distributors. Additionally, the US field communication letter was mailed to the surgeon and facility in regard to the one case of implantation on May 10, 2022. The consignee letter informed the consignee to cease use and distribution of the affected product, check inventory for affected product, complete the response form, return affected product and notify affected consignees. The field surgeon letter and hospital letter informs the consignee to cease use and distribution of the affected product, monitor patients per normal protocol, return affected product and sign and return the response form.
Quantity in Commerce 8 units
Distribution Worldwide distribution - US Nationwide distribution in the states of FL, IN, MO, CA and the country of Canada.
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 = JDI and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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