FDAFDA · Food and drugs·Recall number Z-2949-2018
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
Published September 5, 2018 · Recall initiated: July 18, 2018
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
This unit may be missing the screw/collet Assembly
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DePuy Orthopaedics, Inc.
- Distributor
- The devices were not distributed in the United States. The devices were distributed to the following foreign countries: Great Britain.
- Lot
- Lot: C2KJ24, GTIN: 10603295234135
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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