CLASS II Device recall · Reported 26 Oct 2016 · FDA Enforcement Report
Calix T Peek Lumbar System, Tlif Rasp recalled by X Spine Systems
X Spine Systems is recalling Calix T Peek Lumbar System, Tlif Rasp, distributed in 19 states. The recall was initiated on 17 May 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0126-2017
- FDA event ID
- 74397
- Recalling firm
- X Spine Systems, Miamisburg, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 May 2016
- FDA classified
- 18 Oct 2016
- Reported
- 26 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 May 2016 | Recall initiated by company | |
| 18 Oct 2016 | Classified by FDA | +154 days |
| 26 Oct 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Calix T PEEK Lumbar System, TLIF Rasp
Where it was distributed
Product was shipped to the following states: AZ, CA, CO, FL, GA, ID, IN, KY, LA, MD, MI, MO, NC, NV, NY, PA, PR, TX & WV. Product was also shipped to the following countries: Australia, England, Germany, Italy, Mexico, Portugal & United Kingdom.
ArizonaCaliforniaColoradoFloridaGeorgiaIdahoIndianaKentuckyLouisianaMarylandMichiganMissouriNorth CarolinaNevadaNew YorkPennsylvaniaPuerto RicoTexasWest Virginia
Questions about this recall
Is Calix T Peek Lumbar System, Tlif Rasp recalled?
Yes. X Spine Systems recalled Calix T Peek Lumbar System, Tlif Rasp on 17 May 2016. The recall is Class II and its status is Terminated. Recall number Z-0126-2017.
Why was it 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.
Which lots are affected?
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.
Where was it sold?
Product was shipped to the following states: AZ, CA, CO, FL, GA, ID, IN, KY, LA, MD, MI, MO, NC, NV, NY, PA, PR, TX & WV. Product was also shipped to the following countries: Australia, England, Germany, Italy, Mexico, Portugal & United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from X Spine Systems
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Calix P Peek Lumbar System, Plif Rasp recalled by X Spine Systems | X Spine Systems | Other | 19 states |
| Device | CLASS II | Calix P Peek Lumbar System, Plif Trial recalled by X Spine Systems | X Spine Systems | Other | 19 states |
| Device | CLASS II | Calix T Peek Lumbar System, Tlif Trial recalled by X Spine Systems | X Spine Systems | Other | 19 states |
| Device | CLASS II | Fortex" Pedicle Screw System Continuous Radius Rod recalled | X Spine Systems | Other | 11 states |
| Device | CLASS II | Xpress System Pedicle Screw Assembly recalled by X Spine Systems | X Spine Systems | Other | KS, NV, TX |
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