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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 Recall
Restoration (TM) ADM Trial Cup Holder
see related information
Date Posted April 19, 2010
Recall Status1 Terminated on June 20, 2012
Recall Number Z-1201-2010
Recall Event ID 54478
Product Classification Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate - 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, New Jersey 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/UNDETERMINED: Pending
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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