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U.S. Department of Health and Human Services

Class 2 Device Recall Distal Centralizer Exeter II Hip System

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  Class 2 Device Recall Distal Centralizer Exeter II Hip System see related information
Date Initiated by Firm March 29, 2010
Date Posted May 13, 2010
Recall Status1 Terminated 3 on September 10, 2012
Recall Number Z-1601-2010
Recall Event ID 55199
510(K)Number K974054  
Product Classification Hip Metal/Polymer Semi-Constrained Cemented Prosthesis - Product Code JDI
Product Distal Centralizer, Exeter II Hip System. Catalog number - 0920-2-920.

Intended to be used to centralize the femoral stem within the intramedullary canal. intended to be used with bone cement.
Code Information Lot code - L3988
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Colleen O'Meara
201-831-5970
Manufacturer Reason
for Recall		 Stryker became aware that device labels have incorrectly printed manufacture dates and thus incorrect expiration dates on the product label.
FDA Determined
Cause 2		 Error in labeling
Action Urgent Product Recall letters and Product Accountability Forms have been sent via Fed Ex on March 29, 2010 with return receipt. Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeon were also sent Notification letters and Product Recall Acknowledgment Form on March 29, 2010 with return receipt. The letters explained the issue, the potential hazards, and risk mitigation. The firm asked customers to examine their inventory and hospital locations to identify the affected products. All affected product should be retrieved and returned to their branch or agency warehouse for reconciliation. The attached Product Accountability form should be used to reconcile all product(s) and it should be faxed back to 201-831-6069.
Quantity in Commerce 24 units
Distribution Nationwide Distribution -- FL, MN, & OR.
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 = HOWMEDICA, INC.
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