Excella II Rod recall
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.
Why was Excella II Rod recalled?
Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog No.: SR55110 Lot 1502 and SR55100 Lot 1502
- Product
- 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.
- Recalling firm
- Innovasis, Inc
- Quantity
- 17 units Labeled SR55100 Lot 1502 with SR55110 rods in package
- Distribution
- Distributed in US -- CA; KS; OH; & TX.
- Recall date
- January 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)