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U.S. Department of Health and Human Services

Class 2 Device Recall Restoration ADM System X3 Acetabular Insert

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 Class 2 Device Recall Restoration ADM System X3 Acetabular Insertsee related information
Date Initiated by FirmJune 03, 2011
Date PostedNovember 16, 2011
Recall Status1 Terminated 3 on November 13, 2013
Recall NumberZ-0193-2012
Recall Event ID 60097
510(K)NumberK093644 
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
ProductStryker Restoration ADM System X3 Acetabular Insert Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex France The Restoration ADM System X# Acetabular Insert is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 28mm diameter femoral heads.
Code Information Catalog No.: 1236-2-8XX (XX=46, 48, 50, 52, 54, 56, 58, 60, 62, 64) All Lots K093644
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information ContactMs. Colleen O'Meara
201-831-5970
Manufacturer Reason
for Recall
Stryker Orthopaedics has become ware that there is the potential for interpretation of the product labeling which may lead to an incorrect implant being used.
FDA Determined
Cause 2
Labeling False and Misleading
ActionThe firm, Stryker, sent an "URGENT PRODUCT CORRECTION" letter and Product Correction Bulletin dated June 3, 2011 via Fed Ex to its customers. The letter and bulletin describes the issue, potential hazards, risk mitigation and product correction instructions. The customers were instructed to complete and return the enclosed PRODUCT CORRECTION ACKNOWLEDGMENT FORM within 5 days via fax to: 201-831-6069. If you have any questions, feel free to call (201) 972-2100 or Hip Marketing Team at 201-831-5280.
Quantity in Commerce1677 units
DistributionNationwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LZO
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