Z-2709-2011

Product Brand Name: Versafitcup Double Mobility Liner Inserter Product Generic Name: Versafitcup Double...

Name: Z-2709-2011 Product Brand Name: Versafitcup Double Mobility Liner Inserter Product Generic Name: Versafitcup Double...
Creator: Medacta Usa Inc
Published: 2011-05-23
License: https://open.fda.gov/license/

Medacta USA, Inc. / initiated 2011-05-23 / Terminated / root cause: labeling and UDI

FDA source

Medacta Usa Inc began a recall of Product Brand Name: Versafitcup Double Mobility Liner Inserter Product Generic Name: Versafitcup Double Mobility Liner Inserter Model Number: 01.26.10.0018 The... on 2011-05-23. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2709-2011
Status: Terminated
Initiated: 2011-05-23
Posted: 2011-06-30
Terminated: 2011-07-12
Recalling firm: Medacta USA, Inc.
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.
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
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
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Lot code: 105549

Product code MEH

K083116Class IIVersafit Cup Double Mobility SystemMedacta International S.A. / cleared 2009-04-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)