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U.S. Department of Health and Human Services

Class 2 Device Recall CPT Modular Stem

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  Class 2 Device Recall CPT Modular Stem see related information
Date Initiated by Firm September 13, 2012
Date Posted October 15, 2012
Recall Status1 Terminated 3 on January 15, 2014
Recall Number Z-0062-2013
Recall Event ID 63124
510(K)Number K960658  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10.

CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
Code Information Item 00-8114-001-10, lots 61947699 and 61952551
Recalling Firm/
Manufacturer		 Zimmer, Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact Dawn Kindle
574-372-4807
Manufacturer Reason
for Recall		 Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05; ) and CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10 ) because devices were packaged in incorrect cartons and distributed internationally and domestically. Zimmer received five complaints of this packaging issue.
FDA Determined
Cause 2		 Packaging change control
Action Zimmer Inc. sent an "URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC" letter dated September 13, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Consignees were asked to return all recalled product with a completed Inventory Return Certification Form. Contact the firm at 1-800-348-2759 for questions regarding this notice.
Quantity in Commerce 59 both lots
Distribution Worldwide Distribution-USA (nationwide) including the states of Indiana and Oklahoma and the countries of Australia, Thailand, Malaysia, Germany, India, Bulgaria, Egypt, UK, Russian FED, Slovak, and Brazil.
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 = ZIMMER, INC.
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