Tryptik(r) 2 C-plate Self-tapping Polyaxial Screw 4.0 recall: Labeling Error
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System…
Why was Tryptik(r) 2 C-plate Self-tapping Polyaxial Screw 4.0 recalled?
Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw.
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?
batch: 3-5935
- Product
- TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System…
- Recalling firm
- SPINEART SA
- Quantity
- 60 units
- Distribution
- US Distribution to the state of : CA
- Recall date
- January 24, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)