Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Calix T PEEK Lumbar System Recalled by X Spine Systems Inc Due to The trials and rasps used to prepare the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact X Spine Systems Inc directly.
Affected Products
Calix T PEEK Lumbar System, TLIF Rasp
Quantity: 195 units
Why Was This Recalled?
The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space.
Where Was This Sold?
This product was distributed to 18 states: AZ, CA, CO, FL, GA, ID, IN, KY, LA, MD, MI, MO, NV, NY, NC, PA, TX, WV
About X Spine Systems Inc
X Spine Systems Inc has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report