Recall Z-2067-2014
Innovasis, Inc · initiated July 7, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: E2S47525 Lot 1301 and E2S47535 Lot 1301
Reason for recall
Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
FDA-determined cause: Process control
Action taken
Distributors were notified by e-mail on 7/7/14, with attached copies of the written letter and forms to be printed, signed and returned to Innovasis. Distributors have been instructed to return all inventory in stock.
Details
- Recall number
- Z-2067-2014
- Initiated
- July 7, 2014
- Posted by FDA
- July 16, 2014
- Terminated
- August 11, 2014
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 32
- Distribution
- Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
- Recalling firm
- Innovasis, Inc, Salt Lake City, UT