Spineart Recalls Tryptik 2 C-Plate Screws Due to Labeling Error
Spineart SA is recalling 120 units of Tryptik 2 C-Plate Self-Tapping Screws because the product labeling incorrectly displays a sketch of a self-drilling 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a minor labeling error (incorrect sketch) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Spineart SA is recalling 120 units of the Tryptik 2 C-Plate Self-Tapping Polyaxial Screw, 4.0 mm, length 14 mm (Ref TRY-PS-40 14-S). The recall is limited to Lot 3-5934. These devices are intended for temporary stabilization of the cervical spine during spinal fusion.
The recall was initiated because the product labeling for the self-tapping screw contains a sketch or drawing of a self-drilling screw. This labeling discrepancy may cause confusion regarding the specific type of screw being used.
The affected units were distributed in the United States to the state of California. Healthcare providers and facilities that have received this specific lot of Tryptik 2 C-Plate Self-Tapping Screws should stop using them and contact Spineart SA for further instructions.
The recalled product
- Product
- TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-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
- 120
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: 3-5934
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.
See all 7 products in this recall →Related recalls
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