Caddy - PedFuse recall
Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle…
Why was Caddy - PedFuse recalled?
Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws.
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?
31176, 018652, 018645R, 42011
- Product
- Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle…
- Recalling firm
- SpineFrontier, Inc.
- Quantity
- 11 caddies
- Distribution
- US distribution in states of: CO, DC, MA and TX.
- Recall date
- August 7, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)