Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Pack
FDA device recall Z-0662-2016 · posted 2016-01-19 · Terminated
Recall details
- Recalling firm
- Innovasis, Inc
- Reason for recall
- Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
- Action taken
- Innovasis sent a Voluntary Product Recall letter, dated December 7, 2015 to customers regarding two lots of Excella II titanium rods which were packaged using each other's labels. Customers were asked to check their inventory and either remove the rod from the mislabeled package and request additional rods, or return the unopened packages immediately. The firm will replace all returned inventory upon receipt.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 17 units Labeled SR55100 Lot 1502 with SR55110 rods in package
- Distribution
- Distributed in US -- CA; KS; OH; & TX.
- Date initiated
- 2015-12-07
- Date posted
- 2016-01-19
- Date terminated
- 2016-04-07
- 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 |