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U.S. Department of Health and Human Services

Class 2 Device Recall BIOLOX delta TS Ceramic Femoral Head Articul/eze 12/14 36mm 12

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 Class 2 Device Recall BIOLOX delta TS Ceramic Femoral Head Articul/eze 12/14 36mm 12see related information
Date Initiated by FirmNovember 07, 2014
Date PostedDecember 17, 2014
Recall Status1 Terminated 3 on March 24, 2015
Recall NumberZ-0825-2015
Recall Event ID 69984
510(K)NumberK071830 
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
ProductCeramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
Code Information Lot 7928614 CATALOG NO. : 1365-36-740 Barcode GTIN: 10603295033684
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information ContactKimberly C. Earle
574-371-4917
Manufacturer Reason
for Recall		Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code 1365-36-740) did not fit like the trial; the definite hip construct felt loose. The loosening refers to tissue tension and not the taper connection between the femoral head and stem. The investigations found that the small size sleeve (+1.5 femoral head offset) was incorrectly used in the
FDA Determined
Cause 2		Mixed-up of materials/components
ActionOn 11/7/2014, URGENT INFORMATION - RECALL NOTICE notifications were sent to the affected distributors, hospitals, and doctors with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospitals and doctors were notified via sales consultant visit. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc. Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m. - 5 p.m. EDT). For questions about device recall information provided, please contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. - 5 p.m. EDT).
Quantity in Commerce19 units worldwide
DistributionDistributed in the states of WV, AZ, and AL, and the countries of Germany, and Finland.
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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