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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 Componentsee related information
Date Initiated by FirmJune 04, 2014
Date PostedJune 27, 2014
Recall Status1 Terminated 3 on August 04, 2014
Recall NumberZ-1942-2014
Recall Event ID 68482
510(K)NumberK123380 
Product Classification Prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer - Product Code HSX
ProductStride 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
For Additional Information ContactCustomer 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
ActionFirm 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 Commerce2
DistributionUS Nationwide Distribution in the states of CA, PA, and TX
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HSX
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