Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: 4084-01; M/N X073-5555; UDI: *+M697X07355551/$408401U*
- 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:
- One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.
Product Codes/Lot Numbers:
Lot #: 4084-01; M/N X073-5555; UDI: *+M697X07355551/$408401U*
Distribution:
Distributed in: US, KS, NV, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1512-2015
Related Recalls
Calix T PEEK Lumbar System, TLIF Trial
X Spine Systems
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.
Calix P PEEK Lumbar System, PLIF Trial
X Spine Systems
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.
Calix P PEEK Lumbar System, PLIF Rasp
X Spine Systems
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.