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U.S. Department of Health and Human Services

Class 2 Device Recall Howmedica Osteonics Corp. LFT v40 Femoral Head

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  Class 2 Device Recall Howmedica Osteonics Corp. LFT v40 Femoral Head see related information
Date Initiated by Firm February 03, 2015
Date Posted March 03, 2015
Recall Status1 Terminated 3 on April 07, 2017
Recall Number Z-1241-2015
Recall Event ID 70338
510(K)Number K010757  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product LFT v40 Femoral Head; Catalog Number 6260-9-032;
V40 CoCr LFit Head 32mm/-4.

Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty.
Code Information Lot Code 48681201
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Ms. Christie Samsa
201-831-6365
Manufacturer Reason
for Recall		 Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that the femoral head couldn't be assembled with its corresponding V40 stem trunnion.
FDA Determined
Cause 2		 Under Investigation by firm
Action Branches/Agencies were notified of this action by e-mail on December 19, 2014 and were asked to quarantine affected devices. Notification Letters and Product Accountability Forms were sent to Hospital Risk Management and Chief of Orthopaedics via FedEx (with return receipt) by 2/3/2015.
Quantity in Commerce 9 units
Distribution Distributed in the states of GA, MA, NC, NY & PA.
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 = HOWMEDICA OSTEONICS CORP.
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