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Recall Observatory FDA recall evidence

Device 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.

Z-0198-2015

October 09, 2014

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 69397
Status
Terminated
Classification
Class II
Quantity
138 units
Official record key
device-enforcement:Z-0198-2015

Official wording

Reason: Cleaning process validation failure.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cleaning process validation failure.