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Class 2 Device Recall Locking Cortical Screw |
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Date Initiated by Firm |
December 19, 2013 |
Date Posted |
January 10, 2014 |
Recall Status1 |
Terminated 3 on July 07, 2015 |
Recall Number |
Z-0716-2014 |
Recall Event ID |
67142 |
510(K)Number |
K072083 K072832 K082300
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Product Classification |
Plate, fixation, bone - Product Code HRS
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Product |
Locking Cortical Screw 3.5mmX38mm REF 8161-35-038 |
Code Information |
Catalog Number: 816135038 (8161-35-038) Lot Number Identification: RM244D |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
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For Additional Information Contact |
574-267-6639
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Manufacturer Reason for Recall |
3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified
that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.
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FDA Determined Cause 2 |
Labeling mix-ups |
Action |
URGENT MEDICAL DEVICE RECALL notices were sent to all consignees on December 19, 2013. Distributors who have affected hospitals in their regions were notified and provided with a copy of the notice that went to each hospital. Consignees are being contacted on an individual basis in an attempt to reconcile the product 100%. Fax back forms were provided to all consignees in order for Biomet to track returns. Non-responders will be contacted on an individual basis. |
Quantity in Commerce |
52 |
Distribution |
US Distribution including states of: AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, and VA. |
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 = HRS and Original Applicant = DEPUY ORTHOPAEDICS, INC.
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