Calix T PEEK Lumbar System, TLIF Rasp
Class I - DangerousWhat Should You Do?
- Check if you have this product: Size, 28mm x 10mm x 6mm, Part #:, X034-0360, Lot #:, 23515, 23516, 24295, 24836, 24836s1, 24836S2, 657001, 760913 & Size, 28mm x 10mm x 10mm, Part #:, X034-0364, Lot #:, 23517, 23518, 24296, 24837, 657002, 760914.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- X Spine Systems Inc
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Calix T PEEK Lumbar System, TLIF Rasp
Product Codes/Lot Numbers:
Size, 28mm x 10mm x 6mm, Part #:, X034-0360, Lot #:, 23515, 23516, 24295, 24836, 24836s1, 24836S2, 657001, 760913 & Size, 28mm x 10mm x 10mm, Part #:, X034-0364, Lot #:, 23517, 23518, 24296, 24837, 657002, 760914.
Distribution:
Distributed in: AZ, CA, CO, FL, GA, ID, IN, KY, LA, MD, MI, MO, NC, NV, NY, PA, PR, TX, WV
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0126-2017
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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.