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U.S. Department of Health and Human Services

Class 2 Device Recall Restoration (TM) ADM Trial Cup Holder

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  Class 2 Device Recall Restoration (TM) ADM Trial Cup Holder see related information
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
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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