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U.S. Department of Health and Human Services

Class 2 Device Recall Trochanteric Nail. Long,

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  Class 2 Device Recall Trochanteric Nail. Long, see related information
Date Initiated by Firm March 30, 2012
Date Posted April 30, 2012
Recall Status1 Terminated 3 on March 08, 2013
Recall Number Z-1478-2012
Recall Event ID 61658
510(K)Number K050118  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product REF 28234 Troch Nail, Long 11MM, Right 34 CM
Peritrochanteric Nail System, Rx Sterile
Biomet Trauma Persippany, NJ

Rod, Fixation, Intramedullary and Accessories

Product Usage:
An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromiummolybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
Code Information Item 28334, Lot M486130 
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Mary Hardesty
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall		 The Trochanteric Nail, lot 486130, was mislabeled as a right nail orientation but the contents are actually a left nail orientation
FDA Determined
Cause 2		 Labeling mix-ups
Action Biomet sent an Urgent Medical Device Recall Notice dated April 18, 2012 to all affected consignees. The letter identified the affected product, reason for the recall including risks involved and actions to be taken. The notice provided directions to immediately locate and return the affected product. Receipt Confirmation was requested by calling 800-348-9500 Ext 3009 or 3983. FAX Back Response Form should be completed and returned to 574-372-1683. Questions should be direct to 574-371-3009 or 574-372-3983, M-F, 8 AM to 5 PM.
Quantity in Commerce 30 units in total
Distribution Worldwide Distribution - Nationwide (USA)
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 = HSB and Original Applicant = EBI, L.P.
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