Z-2067-2014 Class II Terminated
FDA device recall Z-2067-2014 was initiated by Innovasis, Inc on July 7, 2014 and is designated Class II. Reason for recall: Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number. The recall status is terminated (terminated August 11, 2014). Affected quantity: 32.
Recall Details
- Product Type
- Devices
- Report Date
- July 23, 2014
- Initiation Date
- July 7, 2014
- Termination Date
- August 11, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32
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.
Distribution Pattern
Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
Code Information
E2S47525 Lot 1301 and E2S47535 Lot 1301