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U.S. Department of Health and Human Services

Class 2 Device Recall Symmetric Total Knee Femoral Component

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  Class 2 Device Recall Symmetric Total Knee Femoral Component see related information
Date Initiated by Firm September 30, 2014
Date Posted October 22, 2014
Recall Status1 Terminated 3 on March 14, 2016
Recall Number Z-0111-2015
Recall Event ID 69420
510(K)Number K080199  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Symmetric Total Knee Femoral Components

Product Usage:
Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).
Code Information Catalog # 22-01-02106; Lot # 1110; Serial # L0259; Size 6R  Catalog #22-01-02106; Lot # 2910; Serial # L0533; Size 6R  Catalog # 22-01-02003, Serial #s L0280,L0283, L0284, L0285, L0287, L0288, L0615, Size 3 L  Catalog # 22-01-02004, Serial # l0358, Size 4L  Catalog # 22-01-02005, Serial # L0809; Size 5L  Catalog #22-01-02006; Serial #s L0692, L0842, L0485, L0483, L0486, L0841, L0844, L0847, Size 6L  Catalog # 22-01-02007, Serial #s L0721, L0786, L0787, L0770, L0772, L0775, Size 7L  Catalog #22-01-02103, Serial #s L0265, L0272, Size 3R  Catalog # 22-01-02104, Serial #s L0479, L0515, L0517, Size 4R  Catalog # 22/01-02106, Serial # L0338, L0508, L0537, L0853, L0867, L0872, L0873, Size 6R  Catalog #22-01-02107, Serial #s L0749, L0758, L0760, L0755, L0759, L0762, Size 7R
Recalling Firm/
Manufacturer		 Signal Medical Corporation
400 Pyramid Dr
Marysville MI 48040-2463
For Additional Information Contact Melinda Finnie
810-364-7070
Manufacturer Reason
for Recall		 Packaging of a device was compromised
FDA Determined
Cause 2		 Packaging
Action Signal Medical sent a Notice letter dated September 30, 2014 to customers. Customers were instructed to carefully inspect devices to ensure package integrity before using. If packaging is compromised it should not be used. Return the affected device and packaging to Signal Medical Corporation. Replacement devices with new packaging configuration is shipped to each location with the old packaging configuration in the event that the packaging is found to be compromised. For questions contact Signal Medical Corp. at 1-800-246-6324.
Quantity in Commerce 41
Distribution Worldwide Distribution - US (Nationwide) in the state of: MO and internationally to: Panama.
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 = JWH and Original Applicant = SIGNAL MEDICAL CORPORATION
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