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U.S. Department of Health and Human Services

Class 2 Device Recall VerSys Hip System Femoral Head

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  Class 2 Device Recall VerSys Hip System Femoral Head see related information
Date Initiated by Firm August 03, 2009
Date Posted November 13, 2009
Recall Status1 Terminated 3 on December 15, 2009
Recall Number Z-0198-2010
Recall Event ID 52836
510(K)Number K953337  
Product Classification Hip Metal/Polymer Semi-Constrained Porous Uncemented Prosthesis - Product Code LPH
Product Zimmer VerSys Hip System Femoral Head, 12/14 taper, 28 mm dia., neck length +0 mm, sterile, Zimmer, Warsaw, IN; REF 8018-28-02.

Intended for mating femoral stems equipped with tapered necks.
Code Information Lot 60378581.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-846-4637
Manufacturer Reason
for Recall		 Manufacturing material may be present on the surface of the implant.
FDA Determined
Cause 2		 Manufacturing material removal
Action An Urgent: Device Recall letter, dated 8/3/2009, was issued to consignees. The letter identified the affected product, stated the reason for the recall, the clinical implications (risks to health), and actions to be taken. Customers are to locate any unused devices and quarantine them immediately, carry out a physical count of affected product and record the data on the Return Certification Form included with the letter, and fax a copy of the completed form back to Zimmer, Inc. at 574-372-4265. Customers are to return the recalled product along with the completed Inventory Return Certification Form. A "Dear Surgeon" letter will be issued to any hospitals where the devices have been implanted.
Quantity in Commerce 104
Distribution Worldwide Distribution -- USA, Brazil, Canada, and Switzerland.
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 = LPH and Original Applicant = ZIMMER, INC.
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