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Product Brand Name: Versafitcup Double Mobility Liner… recallZ-2709-2011 · Medacta Usa Inc · initiated May 23, 2011

Terminated All recalls posted in June 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medacta Usa Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Labeling False and Misleading

What the company is doing

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.

Recall details

Recall number
Z-2709-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 23, 2011
Posted by the FDA
Jun 30, 2011
Recalling firm
Medacta Usa Inc
Quantity
Worldwide: 18 pieces. In the USA: 9 pieces
Product code
MEH
FDA submissions
K083116
Distribution
Worldwide Distribution--USA (nationwide) including the states of CA, ID, IL, and OH, and 9 products to foreign countries.

Product description

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 (models, lots, serial numbers)

Lot code: 105549

Other devices under the same FDA submission

17 devices cleared under K083116 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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