FDAFDA · Food and drugs·Recall number Z-2067-2014
Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.
Published July 23, 2014 · Recall initiated: July 7, 2014
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
Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Innovasis, Inc
- Distributor
- Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
- Lot
- E2S47525 Lot 1301 and E2S47535 Lot 1301
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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