Medacta Usa Inc: Evolis-Femoral Sizer Posterior Reference The femoral sizer posterior reference is a manual orthopedic surgical instrument that is used to determine the trial size and set the external rotation. The femoral sizer is an alternate instrument that can be used in addition to the standard MIS femoral sizer. The Femoral Sizer Posterior Reference intended to be placed on the distal femoral cut and determine the trail size and set the external rotation in preparation for the cut blocks. The femoral sizer posterior reference is intended to be placed on the distal femoral cut and determine the trial size and set the external rotation in preparation for the cut blocks. Indications for Use for the Medacta Evolis Total Knee System are: The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases: - Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis - Avascular necrosis of femoral condyle - Post traumatic loss of joint configuration - Primary implantation failure.

Recall number

Z-2095-2010

Recalling firm

Medacta Usa Inc

Product

Evolis-Femoral Sizer Posterior Reference The femoral sizer posterior reference is a manual orthopedic surgical instrument that is used to determine the trial size and set the external rotation. The femoral sizer is an alternate instrument that can be used in addition to the standard MIS femoral sizer. The Femoral Sizer Posterior Reference intended to be placed on the distal femoral cut and determine the trail size and set the external rotation in preparation for the cut blocks. The femoral sizer posterior reference is intended to be placed on the distal femoral cut and determine the trial size and set the external rotation in preparation for the cut blocks. Indications for Use for the Medacta Evolis Total Knee System are: The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases: - Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis - Avascular necrosis of femoral condyle - Post traumatic loss of joint configuration - Primary implantation failure.

Status

Terminated

Initiated

2009-09-11

Posted

not on file

Terminated

2012-02-29

Reason

Medacta USA Inc is initiating a recall on the Femoral Sizer, an orthopedic manual surgical instrument, because the "L" and "R" markings are mislabeled which would cause incorrect usage.

Root cause

Process design

Action

The firm, Medacta USA Inc, sent an "Urgent Safety Notification" letter dated August 5, 2009, to the customers. The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to check their inventory for devices listed, if found, to immediately sequester them and DO NOT use them in surgery. The customers were ask to please pack the affected femoral sizer(s) posterior reference for shipment to Medacta USA. Medacta informed the customers that Medacta USA personnel will contact them by telephone to provide them with an RMA number and the reworked femoral sizer(s) posterior reference will be returned as soon as they are available. If you have any questions, please feel free to contact the Medacta USA office at 805-437-7085 or contact Ms. Heather Neely directly at 805-886-1069.

Quantity

5

Distribution

Worldwide distribution: USA including states of Texas and Idaho and country of France.

Lot, serial or model codes

Model Number: 02.07.10.0215

510(k) numbers

["K081023"]

PMA numbers

not on file

Product code

JWH

Firm FEI

3006639916

Firm city

Camarillo

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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