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U.S. Department of Health and Human Services

Class 2 Device Recall Mallory Head Calcar Provisional

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  Class 2 Device Recall Mallory Head Calcar Provisional see related information
Date Initiated by Firm March 10, 2010
Date Posted May 26, 2010
Recall Status1 Terminated 3 on October 18, 2010
Recall Number Z-1670-2010
Recall Event ID 55365
510(K)Number K031693  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product Mallory Head Calcar Provisional, 55 mm resection/porous coated, 17.0 mm x 260 mm left, Sterile, REF 11-104939, Biomet Orthopaedics, Warsaw, IN.

Implant device intended for use in femoral revision surgery.
Code Information Lot Number: M059030.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
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.
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 5
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
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 = LPH and Original Applicant = BIOMET, INC.
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