Date Initiated by Firm | January 21, 2010 |
Date Posted | April 19, 2010 |
Recall Status1 |
Terminated 3 on June 20, 2012 |
Recall Number | Z-1201-2010 |
Recall Event ID |
54478 |
Product Classification |
Trial Cup Holder - Product Code MEH
|
Product | Howmedica Restoration ADM Trial Cup Holder;
Non Sterile;
Benoist Girard, Cedex, France;
Distributed by Howmedica Osteonics Corp.
Mahwah, NJ.
The intended use: The Restoration ADM Window Trial is locked onto the Restoration ADM Trial Cup Holder and placed into the acetabulum to evaluate the size and congruity of the preparation for visualization and assessment of fit, contact and congruency of the trial within the acetabulum. |
Code Information |
Catalog number: 1235-0-000; Lot number: G2546019 |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwah NJ 07430
|
For Additional Information Contact | Rich Wolyn 201-831-5158 |
Manufacturer Reason for Recall | The Restoration ADM Trial Cup Holder may not have been assembled correctly. |
FDA Determined Cause 2 | Other |
Action | An "URGENT PRODUCTION OPERATION" letter dated January 21, 2010, was sent to customers via FedEx. The letter described the product, problem and actions to be taken by customer. The customers should follow the instructions on the enclosed PRODUCT BULLETIN. The customer should check their internal inventory immediately and quarantine all affected devices, identify if the device is correctly assembled and complete the Product Correction Acknowledgement Form and fax it to (201) 831-6069.
If you have any questions, feel free to contact Rich Wolyn, Manager, Divisional Regulatory Reporting at (201) 831-5158. |
Quantity in Commerce | 5 units |
Distribution | Nationwide distribution: AZ, CA and OR |
Total Product Life Cycle | TPLC Device Report |
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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.
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