| Class 2 Device Recall Mallory Head Calcar Femoral |  |
Date Initiated by Firm | March 10, 2010 |
Date Posted | May 26, 2010 |
Recall Status1 |
Terminated 3 on October 18, 2010 |
Recall Number | Z-1667-2010 |
Recall Event ID |
55365 |
510(K)Number | K031693 |
Product Classification |
Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
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Product | Mallory Head Calcar Femoral, 34 mm resection/porous coated, 9mm x 170 mm stem, Sterile, REF 11-104902, Biomet Orthopaedics, Warsaw, IN.
Implant device intended for use in femoral revision surgery. |
Code Information |
Lot Numbers: M650320, M298660. |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46582
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For Additional Information Contact | Mary Johnson 574-372-3983 |
Manufacturer Reason for Recall | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep.
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FDA Determined Cause 2 | Process change control |
Action | Biomet Orthopedics issued an "Urgent Medical Device Recall Notice" dated March 10, 2010. The letter went to distributors and users of the recalled device. The letter instructed the consignees to locate the recalled product and return the product to the firm.
For further information, contact Biomet at 1-800-348-9500 or 1-574-372-3983, Monday through Friday, 8:00 AM to 5:00 PM. |
Quantity in Commerce | 10 |
Distribution | Worldwide Distribution -- United States (OH, IN, FL, KY, NV and CA), Mexico, Chile, China, Japan and The Netherlands. |
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 = LPH
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