Zimmer, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0198-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 9, 2014

Date Posted: November 19, 2014

Recall Number: Z-0198-2015

Event ID: 69397

Reason for Recall:

Cleaning process validation failure.

Status: Terminated

Product Quantity: 138 units

Code Information:

Part Number 42-5320-079-02 Lot Number 62613813 Part Number 42-5320-071-02 Lot Number 62625781 Part Number 42-5320-075-01 Lot Number 62619031 Part Number 42-5320-075-01 Lot Number 62619040 Part Number 42-5320-079-01 Lot Number 62626696 Part Number 42-5320-071-01 Lot Number 62625790

Distribution Pattern:

US Nationwide Distribution and countries of Austria ,Belgium, Switzerland, Germany, France, United Kingdom, Italy and South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated