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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 PROFEMURsee related information
Date Initiated by FirmMay 04, 2022
Create DateJune 02, 2022
Recall Status1 Terminated 3 on January 16, 2024
Recall NumberZ-1225-2022
Recall Event ID 90140
510(K)NumberK123434 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
ProductPROFEMUR 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
ActionThe 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 Commerce8 units
DistributionWorldwide distribution - US Nationwide distribution in the states of FL, IN, MO, CA and the country of Canada.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JDI
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