Reported Feb 6, 2019 · Terminated
Calix Lumbar Spinal Implant System
Xtant Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: XTANT MEDICAL INC · 664 Cruiser Ln · Belgrade, MT · 59714-9719
Is this the product you have?
Calix Lumbar Spinal Implant System
27 of 27 products
| Model / number | Product as published |
|---|---|
X034-0172PC | 22mm x 10mm x 8mm PLIF ASSY PC |
X034-0173PC | 26mm x 10mm x 6mm PLIF ASSY PC |
X034-0240PC | 26mm x 10mm x 8mm PLIF ASSY PC |
X034-0241PC | 26mm x 10mm x 10mm PLIF ASSY PC |
X034-0242PC | 26mm x 10mm x 12mm PLIF ASSY PC |
X034-0243PC | 26mm x 10mm x 6mm TLIF ASSY PC |
X034-0280PC | 28mm x 10mm x 7mm TLIF ASSY PC |
X034-0281PC | 28mm x 10mm x 8mm TLIF ASSY PC |
X034-0282PC | 28mm x 10mm x 9mm TLIF ASSY PC |
X034-0283PC | 28mm x 10mm x 10mm TLIF ASSY PC |
X034-0284PC | 28mm x 10mm x 11mm TLIF ASSY PC |
X034-0285PC | 28mm x 10mm x 12mm TLIF ASSY PC |
X034-0286PC | 28mm x 10mm x 13mm TLIF ASSY PC |
X034-0287PC | 28mm x 10mm x 14mm TLIF ASSY PC |
X034-0288PC | 28mm x 10mm x 15mm TLIF ASSY PC |
X034-0289PC | 28mm x 10mm x 16mm TLIF ASSY PC |
X034-0290PC | 26mm x 10mm x 6mm 5o PLIF Assy PC |
X034-0387PC | 26mm x 10mm x 7mm 5o PLIF Assy PC |
X034-0388PC | 26mm x 10mm x 8mm 5o PLIF Assy PC |
X034-0389PC | 26mm x 10mm x 9mm 5o PLIF Assy PC |
- Amount recalled
- 632 units
Where it was sold
Why it was recalled
This recall has been initiated due to a change in packaging and sterilization method to address potential risks of compromised sterilization presented by the existing configuration.
This product could cause temporary or reversible health problems — stop using it.
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