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.
Reported: July 23, 2014 Initiated: July 7, 2014 #Z-2067-2014
Product Description
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.
Reason for Recall
Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
Details
- Recalling Firm
- Innovasis, Inc
- Units Affected
- 32
- Distribution
- Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Innovasis, Inc. Units affected: 32.
Why was this product recalled? ▼
Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 23, 2014. Severity: Moderate. Recall number: Z-2067-2014.
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