Reported Nov 19, 2014 · Terminated
Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and…
Zimmer, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- Persona Stemmed 5
- Degree Cemented Tibia Product UsageThis 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
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Product as published 42-5320-071-02Lot Number 62613813 42-5320-075-01Lot Number 62625781 42-5320-075-01Lot Number 62619031 42-5320-079-01Lot Number 62619040 42-5320-071-01Lot Number 62626696 — Lot Number 62625790 - Amount recalled
- 138 units
Where it was sold
- Nationwide
Why it was recalled
Cleaning process validation failure.
This product could cause temporary or reversible health problems — stop using it.
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