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U.S. Department of Health and Human Services

Class 2 Device Recall ULTIMALX STM

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  Class 2 Device Recall ULTIMALX STM see related information
Date Initiated by Firm May 16, 2012
Date Posted June 29, 2012
Recall Status1 Terminated 3 on March 05, 2013
Recall Number Z-1913-2012
Recall Event ID 61749
510(K)Number K972435  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product ULTIMA*LX STM,POL 10/12TAP/3M

Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped.

Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Code Information Product code: 853158 and Lot numbers: 550633, 642337, XDG35, XDG36, XED10, XFE24, XHL14, XHL15, YAX31, and YGN25.
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact
574-267-8143
Manufacturer Reason
for Recall		 DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
FDA Determined
Cause 2		 Device Design
Action DePuy sent an "URGENT RECALL INFORMATION-FIELD SAFETY NOTICE" letter dated May 16, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact the firm at 574-372-7333 for questions regarding this notice.
Quantity in Commerce 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots
Distribution Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
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 = JOHNSON & JOHNSON PROFESSIONALS, INC.
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