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U.S. Department of Health and Human Services

Class 2 Device Recall Novation Cemented Plus Femoral Stem

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  Class 2 Device Recall Novation Cemented Plus Femoral Stem see related information
Date Initiated by Firm November 07, 2016
Create Date January 17, 2017
Recall Status1 Terminated 3 on August 05, 2019
Recall Number Z-1030-2017
Recall Event ID 75989
510(K)Number K083392  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.
Code Information Serial No. 4110119-4110122, 4120841-4120848, 412748, 4159075-4159082, 4175043-4175054, 4224284-4224299, 4384453-4384471, 4534398-4534399, 4565752-4565760; Catalog No. 160-70-15; UDI: 10885862033086
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Kaya Davis
352-377-1140
Manufacturer Reason
for Recall		 Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
FDA Determined
Cause 2		 Under Investigation by firm
Action In the recall notice sent to agents, dated 11/01/2016, recipients are instructed to cease product distribution, extend knowledge of the recall to their accounts, identify and quarantine any product in inventory, and complete and return the Recall Inventory Response Form. Consignees are instructed to contact their Exactech Representative within 5 days of receipt of the notice to confirm product quantities at each location. Consignees with any questions are instructed to contact Kaya Davis at kaya@exac.com or 1-800-392-2832.
Quantity in Commerce 79 units
Distribution AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.
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 = JDI and Original Applicant = EXACTECH, INC.
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