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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics

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  Class 2 Device Recall Stryker Orthopaedics see related information
Date Initiated by Firm September 08, 2015
Date Posted November 10, 2015
Recall Status1 Terminated 3 on July 25, 2017
Recall Number Z-0261-2016
Recall Event ID 72297
510(K)Number K121308  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.
Code Information Catalog Numbers 6260-5-028; 6260-5-032; 6260-5-132; 6260-5-232, 232; 6260-5-328; 6260-5-332; 6260-5-428; 6260-5-432; 6260-9-0928; 6260-9-032, 6260-9-132, 6260-9-232, 6260-9-328, 6260-9-332, 6260-9-428, 6280-0-128, 6280-0-228, 6280-0-232, 6280-0-332  exp- dates july 2019 to august 2019
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Ms. Michelle Covello
201-831-5000
Manufacturer Reason
for Recall		 Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery.
FDA Determined
Cause 2		 Process design
Action Stryker sent an Urgent Medical Device Recall Notifiications dated September 9 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are asked to complete the attached form and return within 5 days by using email strykerortho6632@stericycle.com or FAX 1-888-965-5803. For further questions please call ( 201) 831-5000.
Quantity in Commerce 201
Distribution Nationwide Distribution
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 = LPH and Original Applicant = HOWMEDICA OSTEONICS CORP
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