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U.S. Department of Health and Human Services

Class 2 Device Recall Vanguard 360 Revision Knee System

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  Class 2 Device Recall Vanguard 360 Revision Knee System see related information
Date Initiated by Firm July 01, 2014
Date Posted August 15, 2014
Recall Status1 Terminated 3 on October 30, 2015
Recall Number Z-2242-2014
Recall Event ID 68931
510(K)Number K093293  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Vanguard 360 Femoral Boss Reamer,
Label: REF 32-488474
VANGUARD 360 1NSTRUMENT
FEMORAL BOSS REAMER
NON-STERILE,
BIOMET ORTHOPEDICS
56 EAST BELL DRIVE
P.O. BOX 587 WARSAW, IN 46581 USA
Code Information Catalog Number: 32-48847 4 Lot Numbers: 022120, 022180, 162530, 232460, 475500 and 475510. 699240, 793350, 793570 Additional Scope: 065030, 095780, 164290, 235870, 253670, 273630, 308620, 418970, 420030, 421210, 570460, 585260, 619690, 708240, 711430, 726490, 816160, 896810, 929690, 953540, 968950
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		 The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.
FDA Determined
Cause 2		 Process change control
Action Urgent Medical Device Recall Notices dated July 15, 2014 were mailed with verification of delivery via FedEx. Response forms were provided to all consignees in order for Biomet to track returns. The letters informed the consignees to return the devices to Biomet and conduct a sub-recall sending the recall letter to all customers.
Quantity in Commerce 461
Distribution California, IA, FL, MD, UT, SC, AL, IL, CO, MA, KS, GA, WA, NV, AR, NH, OK,Pennsylvania, New York, Texas, Virginia, New Jersey, North Carolina, Kentucky, Michigan, Ohio, Wisconsin, Louisiana, Arizona, Indiana, South Dakota, Missouri & Montana. In addition to Korea, B.V., Japan, Puerto Rico, UK, Chile, New Zealand, Australia, & Canada
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 = JWH and Original Applicant = BIOMET, INC.
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