Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in
FDA device recall Z-2067-2014 · posted 2014-07-16 · Terminated
Recall details
- Recalling firm
- Innovasis, Inc
- Reason for recall
- Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 32
- Distribution
- Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
- Date initiated
- 2014-07-07
- Date posted
- 2014-07-16
- Date terminated
- 2014-08-11
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXCELLA III-D SPINAL DEFORMITY SYSTEM (K140238) | Innovasis, Inc. | 2014-05-07 |
| EXCELLA II SPINAL SYSTEM MODEL EC2-00 (K102248) | Innovasis, Inc. | 2010-10-07 |