Excella II Standard Pedicle Screw recall: Labeling Error
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.
Why was Excella II Standard Pedicle Screw recalled?
Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
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?
E2S47525 Lot 1301 and E2S47535 Lot 1301
- 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.
- Recalling firm
- Innovasis, Inc
- Quantity
- 32
- Distribution
- Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
- Recall date
- July 23, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)