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U.S. Department of Health and Human Services

Class 2 Device Recall OSS Cemented IM Stem

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  Class 2 Device Recall OSS Cemented IM Stem see related information
Date Initiated by Firm November 01, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on September 10, 2012
Recall Number Z-0417-2012
Recall Event ID 60447
510(K)Number K002757  
Product Classification Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
Product OSS INTERLOK BOWED IM STEM W/SCREW 14 MM X 150 MM TI 6AL 4V ALLOY.

Hip and knee joint replacement prostheses intended for primary and revision joint arthroplasty for use in cemented applications.
Code Information Item: 150368; Lot 081650  
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall		 Biomet has initiated this action following an investigation which identified that Part 150367, (OSS Cemented 1M Stem 13x150) was incorrectly labeled as part 150368 (OSS Cemented 1M Stem 14x150).
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Biomet, Inc. sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated November 1, 2011 to the one distributor with the affected product. The letter described the product, problem, and actions to be taken by the customer. The letter instructs the customer to immediately locate and remove the affected product from inventory. Additionally, the customer was asked to complete and return a Response Form via fax to 574-372-1683. Call 574-372-3983 for questions related to this notice.
Quantity in Commerce 3 units & 1 pending release
Distribution Distributed only in 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 = KRO and Original Applicant = BIOMET, INC.
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