FDAFDA · Food and drugs·Recall number Z-0784-2014
Zimmer Segmental Systems; Polyethylene Inserts, Size C. Knee replacement.
Published January 29, 2014 · Recall initiated: December 19, 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
After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- Worldwide Distribution. USA nationwide and Germany, with further distribution into EU countries.
- Lot
- Part numbers 00-5850-013-95
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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