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U.S. Department of Health and Human Services

Class 2 Device Recall Stride Femoral Component

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  Class 2 Device Recall Stride Femoral Component see related information
Date Initiated by Firm June 04, 2014
Date Posted June 27, 2014
Recall Status1 Terminated 3 on August 04, 2014
Recall Number Z-1943-2014
Recall Event ID 68482
510(K)Number K123380  
Product Classification Prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer - Product Code HSX
Product Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.
Code Information Lot C785241, Exp 4-2015
Recalling Firm/
Manufacturer		 Blue Belt Technologies MN
2905 Northwest Blvd Ste 40
Plymouth MN 55441-2673
For Additional Information Contact Customer Support
763-452-4922
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.
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
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 = HSX and Original Applicant = BLUE BELT TECHNOLOGIES, INC.
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