Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 7, 2012
ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical Fixation Orthosis, Spondylolisthesis Spinal Fixation The ILLICO MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. When used for a minimally invasive posterior approach ILLlCO¿ MIS Instrumentation is used
The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did not completely fit/pass through the tip of certain Illico Ti Cannulate…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Alphatec Spine, Inc. recalled ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orth… - a moderate-severity action.
ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orth… was recalled by Alphatec Spine, Inc. in November 7, 2012. Reason: The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did n…. Check the official notice for the remedy. Verify recall #Z-0168-2013 with the FDA Devices before acting.
The recall
Alphatec Spine, Inc. issued this moderate-severity FDA Devices recall-The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did n….
- Moderate
- severity level
- Class II
- classification
- November 7, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0168-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0168-2013) was formally reported on November 7, 2012, with the manufacturer initiating the action on September 25, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Alphatec Spine, Inc. is listed as the recalling firm, operating out of Carlsbad, CA. Federal records list the affected scope as 209 screws.
The documented reason for this recall is: The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did not completely fit/pass through the tip of certain Illico Ti Cannulated Polyaxial Screws, therefore rendering … Distribution data in the federal record shows the product reached: Nationwide Distribution including AZ, IL, CA, SC, TN, TX, GA, CT, NY, FL, OK, LA, MO, NV,and UT.. 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, 3 from FDA Devices - 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.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
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.
Affected scope
209 screws
Related Recalls
6
3 from same agency
Product description
ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical Fixation Orthosis, Spondylolisthesis Spinal Fixation The ILLICO MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. When used for a minimally invasive posterior approach ILLlCO¿ MIS Instrumentation is used in conjunction with polyaxial screw components. The ILLICO MIS Posterior Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the ILLICO MIS Posterior Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
Reason for recall
The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did not completely fit/pass through the tip of certain Illico Ti Cannulated Polyaxial Screws, therefore rendering such screws nonfunctional.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0168-2013 |
| Date reported | November 7, 2012 |
| Date initiated | September 25, 2012 |
| Recalling firm | Alphatec Spine, Inc. |
| Firm location | Carlsbad, CA |
| Affected scope | 209 screws |
| Distribution | Nationwide Distribution including AZ, IL, CA, SC, TN, TX, GA, CT, NY, FL, OK, LA, MO, NV,and UT. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0168-2013) 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? ▼
ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical Fixation Orthosis, Spondylolisthesis Spinal Fixation The ILLICO MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. When used for a minimally invasive posterior approach ILLlCO¿ MIS Instrumentation is used in conjunction with polyaxial screw components. The ILLICO MIS Posterior Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the ILLICO MIS Posterior Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.. Recalled by Alphatec Spine, Inc.. Units affected: 209 screws.
Why was this product recalled? ▼
The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did not completely fit/pass through the tip of certain Illico Ti Cannulated Polyaxial Screws, therefore rendering such screws nonfunctional.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 7, 2012. Severity: Moderate. Recall number: Z-0168-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including AZ, IL, CA, SC, TN, TX, GA, CT, NY, FL, OK, LA, MO, NV,and UT..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0168-2013) 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 November 7, 2012. 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.