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U.S. Department of Health and Human Services

Class 2 Device Recall Modular Femoral Neck

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  Class 2 Device Recall Modular Femoral Neck see related information
Date Initiated by Firm May 08, 2008
Date Posted August 26, 2008
Recall Status1 Terminated 3 on September 08, 2009
Recall Number Z-1868-2008
Recall Event ID 48427
510(K)Number K000817  
Product Classification Prosthesis - Product Code JDI
Product Encore Modular Femoral Neck, 12 degree/35 mm; Ref #410-35-112; distributed by Encore Medical, Austin, TX 78758.

Designed to ensure the proper anteversion and femoral head orientation in the acetabulum.
Code Information Lots #53876569, Exp 7/23/2013; 53869022, and lot 53873037
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact
512-832-9500
Manufacturer Reason
for Recall		 Product not manufactured to specifications; modular femoral necks found to contain 24 scallops, instead of the standard 12.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Firm notified sales agents of recall on 05/08/08 via an Urgent: Medical Device Recall letter. Sales agents asked to immediately examine their inventory and quarantine product subject to recall. Agents are asked to notify their customers if they had further distributed the product. All product must be returned to Encore along with the response form.
Quantity in Commerce 20 units
Distribution Worldwide Distribution --- USA including states of IN, KS, GA, WA, SD, and countries of Greece and Australia.
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 = OSTEOIMPLANT TECHNOLOGY, INC.
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