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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm April 15, 2005
Date Posted August 03, 2005
Recall Status1 Terminated 3 on August 11, 2005
Recall Number Z-1066-05
Recall Event ID 31823
510(K)Number K953337  
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
Product Zimmer brand Versys Hip System Femoral Head 12/14 taper, 32 mm dia., neck length +0mm; Product 00-8018-032-02.
Code Information Lot 60252787.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact Connie Morgan
800-846-4637
Manufacturer Reason
for Recall		 May be mislabeled as to dimensions; may be 12/14 taper, 28mm dia., neck length +3.5mm.
FDA Determined
Cause 2		 Other
Action Consignees were notified via certified letter dated 4/6/05.
Quantity in Commerce 38
Distribution Nationwide and 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 = JDI and Original Applicant = ZIMMER, INC.
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