FDAFDA · Food and drugs·Recall number Z-0076-2014
Zimmer¿ Unicompartmental Knee Femoral Component. Indicated for patients with painful and/or disabling knee joint.
Published November 6, 2013 · Recall initiated: August 30, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.
- Lot
- Part Number Range:00-5842-011/017-01/02
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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