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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 22, 2005
Date Posted September 21, 2005
Recall Status1 Terminated 3 on July 07, 2012
Recall Number Z-1548-05
Recall Event ID 31392
510(K)Number K042778  
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
Product Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6121H QTY 1 3.5 x 10.5 mm Bio-Anchor with Disposable Driver, Preloaded with One #2 Herculine Suture***STERILE ***Linvatec A ConMed Company LINVATEC CORPORATION LARGO, FL 33773 USA***''.
Code Information Lot #''s BBB65719, BBB67474, BBB68490
Recalling Firm/
Manufacturer		 Linvatec Corp.
11311 Concept Blvd
Largo FL 33773-4908
Manufacturer Reason
for Recall		 Linvatec has determined there is a possibility the pouch Tyvek header to foil longitudinal seal was not properly sealed by Bemis Flexible Packaging, in all pouches, prior to sterilization by Linvatec. Therefore there is a potential for compromised sterility of the devices.
FDA Determined
Cause 2		 Other
Action Linvatec will issue the recall notifications to all Linvatec direct consignees and customers by mailings using UPS overnight delivery or equivalent method.
Quantity in Commerce 289 Units
Distribution Product was shipped to consignees and customers (sales representatives, domestic customers, international customers, and international distributors and affiliates).
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 = LINVATEC CORP.
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