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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm June 18, 2003
Date Posted September 24, 2003
Recall Status1 Terminated 3 on September 23, 2003
Recall Number Z-1288-03
Recall Event ID 26618
510(K)Number K911684  
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
Product Stanmore modular hip system; Stanmore CoCr femoral size 3 straight stem; part 164253
Code Information 230240, 267147, 286360, 299075, 322326, 336749, 336750, 353706, 375330, 376153, 377974, 381383, 384128, 386132, 430623, 430624, 431204, 432709, 447474, 449861, 506390
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 East Bell Drive
Warsaw IN 46582
For Additional Information Contact
800-348-9500 Ext. 1305
Manufacturer Reason
for Recall		 The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
FDA Determined
Cause 2		 Other
Action Distributors were sent a letter on June 18, 2003 via FedEx. This mailing contained labels and the distributors were instructed to affix the label to the inventory consigned to hospitals within their territory.
Quantity in Commerce 25
Distribution United States
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 = JDI and Original Applicant = BIOMET, INC.
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