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U.S. Department of Health and Human Services

Class 2 Device Recall Mallory Head Calcar Femoral

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 Class 2 Device Recall Mallory Head Calcar Femoralsee related information
Date Initiated by FirmMarch 10, 2010
Date PostedMay 26, 2010
Recall Status1 Terminated 3 on October 18, 2010
Recall NumberZ-1669-2010
Recall Event ID 55365
510(K)NumberK031693 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
ProductMallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 170 mm stem, Sterile, REF 11-104905, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femoral revision surgery.
Code Information Lot Numbers: M205110, M205120, M562570, M565210, M427660, M110390.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
For Additional Information ContactMary 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
ActionBiomet 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 Commerce21
DistributionWorldwide Distribution -- United States (OH, IN, FL, KY, NV and CA), Mexico, Chile, China, Japan and The Netherlands.
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 = LPH
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