Spineart Recalls Tryptik 2 C-Plate Screw Due to Labeling Error
Spineart SA is recalling 9 units of Tryptik 2 C-Plate Self-Tapping Screws because the product labeling displays a sketch of a self-drilling screw instead of the correct self-tapping screw.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a packaging and labeling discrepancy where the wrong screw type is depicted in the drawing. This falls under the 'Low' severity criteria for packaging-only problems or documentation issues, with no reported injuries or functional defects.
Plain-English summary
Spineart SA is recalling 9 units of the Tryptik 2 C-Plate Self-Tapping Polyaxial Screw, 4.5 mm, length 12 mm, reference TRY-PS-45 12-S. The recall is limited to units with batch number 3-5936 that were distributed to California.
The recall was initiated because the product labeling for the Tryptik 2-C-Plate Self Tapping screw, reference TRY-PS 40, Lot 3-5934, contains a sketch or drawing of a self-drilling screw. This labeling discrepancy does not match the actual self-tapping screw product being recalled.
The Tryptik 2C-Plate Anterior Cervical Plate System is intended for temporary stabilization of the cervical spine (C2-C7) during spinal fusion. Healthcare providers and patients who have received or used these specific units should contact Spineart SA for further instructions.
The recalled product
- Product
- TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion
- Manufacturer
- SPINEART SA
- Hazard
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- batch: 3-5936
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 7 recalled by SPINEART SA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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