| Class 2 Device Recall Trochanteric Nail. Long, | |
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
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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
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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 |
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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 = HSB
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