Recall Z-0338-2018 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
SPINEART SA
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 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 orig
| Date | Nov 27, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Error in labeling |
| 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 |
| Quantity | 60 units |
| Distribution | US Distribution to the state of : CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153042 | TRYPTIK2C-plate Anterior Cervical Plate System Spineart, Mar 28, 2016 |