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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Trabecular Metal" Femoral Cone Augment

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  Class 2 Device Recall Zimmer Trabecular Metal" Femoral Cone Augment see related information
Date Initiated by Firm July 05, 2010
Date Posted September 20, 2010
Recall Status1 Terminated 3 on December 22, 2010
Recall Number Z-2440-2010
Recall Event ID 56390
510(K)Number K040630  
Product Classification Knee Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis - Product Code JWH
Product TRABECULAR METAL ¿ FEMORAL CONE AUGMENT - RIGHT, Part Number: 00-5450-012-32.

The objective of the Trabecular Metal Femoral Cone Augment is to fill and reconstruct large bone deficiencies and cavitary defects in the distal femur and to provide for a stable platform for an LCCK or Rotating Hinge Knee femoral component.
Code Information Lot: 60683036, Manufactured: 6/07/2007 
Recalling Firm/
Manufacturer		 Zimmer Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact
574-372-4463
Manufacturer Reason
for Recall		 Zimmer, Inc. has determined that there is a potential for the packages to be mislabeled. Specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augment component may be labeled as a left.
FDA Determined
Cause 2		 Labeling mix-ups
Action Zimmer, Inc. sent Urgent: Device Removal letters, dated July 9, 2010, identifying the affected product and stating the issue. Specifically, the left femoral cone augment component may be labeled as a right and the right femoral cone augment component may be labeled as a left. The letter also discussed the clinical implications along with required actions. Customers are to perform a physical count of all affected product and record the data on the Inventory Return Certification Form included with the letter. In addition, customers should complete and return the Inventory Certification and User Facility/HCP Documentation Forms. Affected product along with the Inventory Return Certification Form should be returned. Zimmer, Inc. should be contacted at 1-800-613-6131 if there are any questions or need for additional information.
Quantity in Commerce 50 total
Distribution Worldwide Distribution -- USA, Canada, Singapore, Australia, and Switzerland, Spain, UK, Sweden, and Israel.
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 = JWH and Original Applicant = IMPLEX CORP.
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