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 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. Intended for use in the non-cervical area of the spine.
This recall has been terminated (originally issued January 19, 2016).
- Company
- Innovasis, Inc
- Recall Initiated
- December 7, 2015
- Posted
- January 19, 2016
- Terminated
- April 7, 2016
- Recall Number
- Z-0662-2016
- Quantity
- 17 units Labeled SR55100 Lot 1502 with SR55110 rods in package
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
Distribution
Distributed in US -- CA; KS; OH; & TX.
Lot / Code Info
Catalog No.: SR55110 Lot 1502 and SR55100 Lot 1502
Root Cause
Labeling mix-ups
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.
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