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Class 2 Device Recall Stride Femoral Component |
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Date Initiated by Firm |
June 04, 2014 |
Date Posted |
June 27, 2014 |
Recall Status1 |
Terminated 3 on August 04, 2014 |
Recall Number |
Z-1942-2014 |
Recall Event ID |
68482 |
510(K)Number |
K123380
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Product Classification |
Prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer - Product Code HSX
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Product |
Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis. |
Code Information |
Lot C785231, Exp 5-2015 |
Recalling Firm/ Manufacturer |
Blue Belt Technologies MN 2905 Northwest Blvd Ste 40 Plymouth MN 55441-2673
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For Additional Information Contact |
Customer Support 763-452-4922
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Manufacturer Reason for Recall |
Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral.
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FDA Determined Cause 2 |
Labeling mix-ups |
Action |
Firm initiated recall on 6/4/2014 by Blue Belt Technologies representatives hand delivering an Urgent Medeical Device Recall letter. The letter was addressed to the attention of Safety Officer/Regulatory Compliance Officer. The letter described the issue of the labeling mix-up, asked for devices to be quarantined, and stated that a Blue Belt Technologies Clinical Specialist will be contacting the consignee or return and replacement. A Receipt Acknowledgement form was asked to be returned by fax or mail. |
Quantity in Commerce |
2 |
Distribution |
US Nationwide Distribution in the states of CA, PA, and TX |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = HSX and Original Applicant = BLUE BELT TECHNOLOGIES, INC.
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