TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-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 in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
FDA Recall Z-0341-2018 · Posted None
Recalling FirmSPINEART SA
Recall StatusTerminated
Product CodeKWQ
Date Initiated2017-11-27
Date Terminated2019-08-27
Product Quantity15 units
Reason for Recall
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.
Firm Action
Spineart sent an Urgent Medical Device letter by email dated November 27, 2017. The letter stated the following:
"Out of an abundance of caution", we have decided to recall the concerned products.
Please carefully follow instructions detailed below:
1. Immediately examine your inventory and quarantine product subject to recall.
2. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall by using this document.
3. Collect and quarantine all products.
4. Send back all products and the enclosed Response Form to Spineart Geneva E-mail: [email protected]."
For further questions, please call (949) 313-6400..
Root Cause
Error in labeling
Distribution Pattern
US Distribution to the state of : CA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.