XTant Medical Recalls Calix Lumbar Spinal Implants for Sterilization Concerns
XTant Medical is recalling 632 Calix Lumbar Spinal Implant System units due to a change in packaging and sterilization method to address potential risks of compromised sterilization.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, and the hazard is theoretical (potential compromised sterilization), which aligns with the High severity criteria.
Plain-English summary
XTant Medical Inc. is recalling 632 units of the Calix Lumbar Spinal Implant System. The recall involves various sizes of PLIF and TLIF assemblies, including specific reference numbers such as X034-0172PC through X034-0396PC. These devices are intended for use with supplemental spinal fixation systems in the lumbosacral spine.
The recall was initiated due to a change in packaging and sterilization method. This change was made to address potential risks of compromised sterilization presented by the existing configuration. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
The affected units were distributed in the United States to the states of Arizona, California, Colorado, Florida, Indiana, Louisiana, Mississippi, Georgia, Michigan, Nevada, West Virginia, and Texas. The devices were also distributed internationally to Australia, Mexico, Portugal, the United Kingdom, and Italy. Patients who have received these implants should contact their healthcare provider for guidance.
The recalled product
- Product
- Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x 8mm PLIF ASSY PC, REF X034-0173PC 26mm x 10mm x 6mm PLIF ASSY PC, REF X034-0240PC 26mm x 10mm x 8mm PLIF ASSY PC, REF X034-0241PC 26mm x 10mm x 10mm PLIF ASSY PC, REF X034-0242P
- Manufacturer
- XTANT MEDICAL INC
- Category
- Medical Device — Spinal Implant
- Affected units
- 632
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UPC/UDI/Lot numbers REF X034-0172PC
- M697X0340172PC1 19211-2
- 21017-1 REF X034-0173PC
- M697X0340173PC1 041790
- 17075-5
- 17196-3 REF X034-0240PC
- M697X0340240PC1 042050
- 18890-1
- 20745-1
- 17196-12
- 18216-1 REF X034-0241PC
- M697X0340241PC1 039171
- 042071
- 054614
- 056529
- 057161
- 058525
- 17196-13
- 20745-2 REF X034-0242PC
- M697X0340242PC1 20962
Distribution
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