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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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…
- 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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