ModerateClass IITerminated

FDA Devices recall · Reported February 6, 2019

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 X034-0242PC 26mm x 10mm x 12mm PLIF ASSY PC, REF X034-0243PC 26mm x 10mm x 6mm TLIF ASSY PC, REF X034-0280PC 28mm x 10mm x 7mm TLIF ASSY PC, REF X034-0281PC 28mm x 10mm x 8mm TLIF ASSY PC, REF X034-0282PC 28mm x 10mm x 9mm TL

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on February 6, 2019. Severity: Moderate. Recall number: Z-0790-2019.

Q: Where was the recalled product distributed?

Distribution: US Distribution in states of: AZ, CA, CO, FL, IN, LA, MS, GA, KA, MI, NV, WV, TX, and internationally to: Australia, Mexico, Portugal, UK, and Italy..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-0790-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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 configuratio…

Recall #: Z-0790-2019
Affected scope: 632 units
Initiated: December 19, 2018

Compiled from official public sources by the editorial team.

Verify with FDA Devices →

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Xtant Medical INC recalled Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22m… - a moderate-severity action.

Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22m… was recalled by Xtant Medical INC in February 6, 2019. Reason: This recall has been initiated due to a change in packaging and sterilization method to address potential ris…. Check the official notice for the remedy. Verify recall #Z-0790-2019 with the FDA Devices before acting.

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The recall

Xtant Medical INC issued this moderate-severity FDA Devices recall-This recall has been initiated due to a change in packaging and sterilization method to address potential ris….

Moderate
severity level: 632 units
affected scope: Class II
classification: February 6, 2019
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0790-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-0790-2019) was formally reported on February 6, 2019, with the manufacturer initiating the action on December 19, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Xtant Medical INC is listed as the recalling firm, operating out of Belgrade, MT. Federal records list the affected scope as 632 units.

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: US Distribution in states of: AZ, CA, CO, FL, IN, LA, MS, GA, KA, MI, NV, WV, TX, and internationally to: Australia, Mexico, Portugal, UK, and Italy.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

632 units

Related Recalls

0 from same agency

Product description

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 X034-0242PC 26mm x 10mm x 12mm PLIF ASSY PC, REF X034-0243PC 26mm x 10mm x 6mm TLIF ASSY PC, REF X034-0280PC 28mm x 10mm x 7mm TLIF ASSY PC, REF X034-0281PC 28mm x 10mm x 8mm TLIF ASSY PC, REF X034-0282PC 28mm x 10mm x 9mm TLIF ASSY PC, REF X034-0283PC 28mm x 10mm x 10mm TLIF ASSY PC, REF X034-0284PC 28mm x 10mm x 11mm TLIF ASSY PC, REF X034-0285PC 28mm x 10mm x 12mm TLIF ASSY PC, REF X034-0286PC 28mm x 10mm x 13mm TLIF ASSY PC, REF X034-0287PC 28mm x 10mm x 14mm TLIF ASSY PC, REF X034-0288PC 28mm x 10mm x 15mm TLIF ASSY PC, REF X034-0289PC 28mm x 10mm x 16mm TLIF ASSY PC, REF X034-0290PC 26mm x 10mm x 6mm 5o PLIF Assy PC, REF X034-0387PC 26mm x 10mm x 7mm 5o PLIF Assy PC, REF X034-0388PC 26mm x 10mm x 8mm 5o PLIF Assy PC, REF X034-0389PC 26mm x 10mm x 9mm 5o PLIF Assy PC, REF X034-0390PC 26mm x 10mm x 10mm 5o PLIF Assy PC, REF X034-0391PC 26mm x 10mm x 11mm 5o PLIF Assy PC, REF X034-0392PC 26mm x 10mm x 12mm 5o PLIF Assy PC, REF X034-0393PC 26mm x 10mm x 13mm 5o PLIF Assy PC, REF X034-0394PC 26mm x 10mm x 14mm 5o PLIF Assy PC, REF X034-0395PC 26mm x 10mm x 15mm 5o PLIF Assy PC, REF X034-0396PC This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

Reason for recall

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0790-2019
Date reported	February 6, 2019
Date initiated	December 19, 2018
Recalling firm	Xtant Medical INC
Firm location	Belgrade, MT
Affected scope	632 units
Distribution	US Distribution in states of: AZ, CA, CO, FL, IN, LA, MS, GA, KA, MI, NV, WV, TX, and internationally to: Australia, Mexico, Portugal, UK, and Italy.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

632 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0790-2019) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product 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.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on February 6, 2019. Severity: Moderate. Recall number: Z-0790-2019.

Where was the recalled product distributed? ▼

Distribution: US Distribution in states of: AZ, CA, CO, FL, IN, LA, MS, GA, KA, MI, NV, WV, TX, and internationally to: Australia, Mexico, Portugal, UK, and Italy..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-0790-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 6, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.