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U.S. Department of Health and Human Services

Class 2 Device Recall Versafitcup Double Mobility Liner Inserter

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 Class 2 Recall
Versafitcup Double Mobility Liner Inserter
see related information
Date Posted June 30, 2011
Recall Status1 Terminated on July 12, 2011
Recall Number Z-2709-2011
Recall Event ID 59043
Premarket Notification
510(K) Number
K083116 
Product Classification Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate - Product Code MEH
Product Product Brand Name: Versafitcup Double Mobility Liner Inserter Product Generic Name: Versafitcup Double Mobility Liner Inserter Model Number: 01.26.10.0018 The hip prosthesis is designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature. The patients condition should be due to one or more of: " Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriactic arthritis, Congenital hip dysplasia, Ankylosing spondylitis. " Avascular necrosis of the femoral head. " Acute traumatic fracture of the femoral head or neck. " Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present. " Dislocation risks.
Code Information Lot code: 105549
Recalling Firm/
Manufacturer
Medacta Usa Inc
4725 Calle Quetzal Ste B
Camarillo, California 93012-8429
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Adam Gross
858-705-0350
Manufacturer Reason
for Recall
Medacta International has recently realized that the base of the Liner Inserter Ref 01.26.10.0018 Lot 105549 of the Versafitcup Double Mobility system could become rusty after the washing procedures. This is due to an incorrect raw material used by one of our suppliers during the production phase of this lot. For this reason, Medacta International has made the decision to remove all the pieces
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
Action Medacta USA sent an "URGENT SAFETY NOTIFICATION-VERSAFITCUP DM LINER INSERTER" letter dated May 23, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory for the affected device, immediately sequester it and not use the device in surgery. The letter instructs customers to pack the affected device for shipment to Medacta USA under Return Material Authorization 1590. Customer will receive a replacement within a few days. Questions regarding this recall are directed to the Director of Regulatory and Quality at 805-437-7085 ext. 26.
Quantity in Commerce Worldwide: 18 pieces. In the USA: 9 pieces
Distribution Worldwide Distribution--USA (nationwide) including the states of CA, ID, IL, and OH, and 9 products to foreign countries.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MEH and Original Applicant = MEDACTA INTERNATIONAL, SA
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