FDAFDA · Food and drugs·Recall number Z-2060-2015
ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
Published July 22, 2015 · Recall initiated: June 17, 2015
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
A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fatigue of implant prior to sufficient fracture healing, which may result in need for implant removal and revision of fracture fixation to assure proper healing and avoid fracture malunion or nonunion.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- Worldwide distribution. US states of NC and AK; Taiwan, Japan, and Germany.
- Lot
- Part 47-2492-320-10; lot 62763724
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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