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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Femoral Stem

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  Class 2 Device Recall Zimmer Femoral Stem see related information
Date Initiated by Firm May 15, 2009
Date Posted July 06, 2009
Recall Status1 Terminated 3 on November 12, 2009
Recall Number Z-1615-2009
Recall Event ID 52128
510(K)Number K992667  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, uncemented - Product Code LWJ
Product Zimmer femoral stem, revision taper, 15 mm diameter, 185 mm stem length, w/compression nut, sterile, Zimmer, Warsaw, IN; Model Number: 9982-15-18.

Cement-less total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques. Devices placed in femoral canal. A variety of stem and body components are provided to achieve fixation and restore joint kinematics.
Code Information Lot Number: 60698102.
Recalling Firm/
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
Manufacturer Reason
for Recall
The threads on the screw are incomplete/non-functional.
FDA Determined
Cause 2
Process control
Action Zimmer, Inc. began Consignee notification of the affected device via telephone on May 15, 2009. A certified "Urgent: Device Recall" notification dated May 21, 2009 was sent to all consignees instructing them of the affected device, to stop use of and return it with a Return Certification form. The Return Verification form should also be faxed to Zimmer, Inc. at 1-574-372-4265. For shipping assistance, questions or other concerns, contact Zimmer, Inc. at 1-800-613-6131.
Quantity in Commerce 10
Distribution Worldwide Distribution -- US states of IA, NE and CA and countries of Canada, Switzerland, United Kingdom, Hungary, Netherlands and Slovakia.
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 = LWJ and Original Applicant = ZIMMER, INC.