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Terminated

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.

FDA Recall Z-2709-2011 · Posted 2011-06-30

Recalling FirmMedacta Usa Inc
Recall StatusTerminated
Product CodeMEH
Date Initiated2011-05-23
Date Terminated2011-07-12
Product QuantityWorldwide: 18 pieces. In the USA: 9 pieces

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

Firm 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.

Root Cause

Labeling False and Misleading

Distribution Pattern

Worldwide Distribution--USA (nationwide) including the states of CA, ID, IL, and OH, and 9 products to foreign countries.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083116VERSAFIT CUP DOUBLE MOBILITY SYSTEMMedacta International S.A. · 2009-04-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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