Recall Z-0198-2015— Zimmer, Inc.

Name: FDA recall Z-0198-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-09

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2014-10-09, terminated 2015-06-24. It names one FDA 510(k) clearance: K113369. Product: Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device is intended for cemented use only.. Reason: Cleaning process validation failure..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-10-09
Terminated: 2015-06-24
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K113369 — ZIMMER PERSONA KNEE SYSTEMZimmer, Inc.·cleared 2012-03-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device is intended for cemented use only.

Reason for recall

Cleaning process validation failure.

Data sourced from openFDA. This site is unofficial and independent of the FDA.