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U.S. Department of Health and Human Services

Class 2 Device Recall Locking Cortical Screw

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 Class 2 Device Recall Locking Cortical Screwsee related information
Date Initiated by FirmDecember 19, 2013
Date PostedJanuary 10, 2014
Recall Status1 Terminated 3 on July 07, 2015
Recall NumberZ-0716-2014
Recall Event ID 67142
510(K)NumberK072083 K072832 K082300 
Product Classification Plate, fixation, bone - Product Code HRS
ProductLocking 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
For Additional Information Contact
574-267-6639
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.
FDA Determined
Cause 2		Labeling mix-ups
ActionURGENT 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 Commerce52
DistributionUS Distribution including states of: AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, and VA.
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 = HRS
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