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U.S. Department of Health and Human Services

Class 2 Device Recall Mallory Head 4 Finned Acetabular Shell 50mm

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 Class 2 Device Recall Mallory Head 4 Finned Acetabular Shell 50mmsee related information
Date Initiated by FirmJanuary 09, 2015
Date PostedFebruary 17, 2015
Recall Status1 Terminated 3 on October 22, 2015
Recall NumberZ-1122-2015
Recall Event ID 70438
510(K)NumberK030055 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
ProductMallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
Code Information Catalog Number: 13-104150 Lot Number Identification: 364600
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information ContactAudrey Daenzer
574-267-6639
Manufacturer Reason
for Recall		Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.
FDA Determined
Cause 2		Packaging process control
ActionBiomet notified all domestic and foreign customers via FEDEx overnight on 1/9/2015. Response forms were provided, customers were instructed to notify hospital personnel if product was further distributed, and remove recalled products from circulation. Replacement parts were made available, customers may contact Audrey Daenzer, Field Action Specialist, Regulatory Compliance Biomet, Inc., audrev.daenzer@biomet.com, or 574-372-1570 Monday- Friday 8 AM to 5 PM.
Quantity in Commerce17
DistributionDistributed in the states of VA and TX and the country of Japan.
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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