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

FDA device recall Z-2709-2011 · posted 2011-06-30 · Terminated

Recall details

Recalling firm

Medacta Usa Inc

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

Action taken

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

Status

Terminated

Product code

MEH

Quantity affected

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.

Date initiated

2011-05-23

Date posted

2011-06-30

Date terminated

2011-07-12

Location

Camarillo, CA

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