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Class 2 Device Recall |
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Date Initiated by Firm |
February 22, 2005 |
Date Posted |
September 21, 2005 |
Recall Status1 |
Terminated 3 on July 07, 2012 |
Recall Number |
Z-1550-05 |
Recall Event ID |
31392 |
510(K)Number |
K020377
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Product Classification |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
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Product |
Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF*** QTY 1***Hornet Disposable Inserter, BioStinger Implant***STERILE***Linvatec, LINVATEC CORPORATION LARGO, FL 33733 USA***''. |
Code Information |
Lot #''s BBB32927, BBB33173, BBB34093, BBB40588, BBB41400, BBB43500, BBB44122, BBB47021, BBB51947, BBB54961, BBB61003, BBB63978, BBB67469, BBB71590, BBB32928, BBB33170, BBB33172, BBB34090, BBB35000, BBB37713, BBB40589, BBB41401, BBB42354, BBB43059, BBB45125, BBB47861, BBB48837, BBB49882, BBB50769, BBB57155, BBB57550, BBB61002, BBB62845, BBB66407, BBB68489, BBB33174, BBB36672, BBB50768, BBB62844, BBB69766. |
Recalling Firm/ Manufacturer |
Linvatec Corp. 11311 Concept Blvd Largo FL 33773-4908
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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.
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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 |
3,586 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
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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.
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510(K) Database |
510(K)s with Product Code = JDI and Original Applicant = LINVATEC CORP.
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