Piranha Screw 4.0 x 12mm recall
Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of the cervical…
Why was Piranha Screw 4.0 x 12mm recalled?
Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
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?
Part No. CSF-40-12, Lot No. 132635
- Product
- Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of the cervical…
- Recalling firm
- Amendia, Inc dba Spinal Elements
- Quantity
- 82 units
- Distribution
- US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX.
- Recall date
- December 20, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)