Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 20, 2017
Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjustment to fusion in the treatment of degenerative disc disease (DDD), sponylolisthesis, spinal stenosis, tumors, trauma (i.e. fr
Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Amendia, Inc dba Spinal Elements recalled Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical P… - a moderate-severity action.
Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical P… was recalled by Amendia, Inc dba Spinal Elements in December 20, 2017. Reason: Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually …. Check the official notice for the remedy. Verify recall #Z-0239-2018 with the FDA Devices before acting.
The recall
Amendia, Inc dba Spinal Elements issued this moderate-severity FDA Devices recall-Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually ….
- Moderate
- severity level
- 82 units
- affected scope
- Class II
- classification
- December 20, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0239-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0239-2018) was formally reported on December 20, 2017, with the manufacturer initiating the action on November 13, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Amendia, Inc dba Spinal Elements is listed as the recalling firm, operating out of Marietta, GA. Federal records list the affected scope as 82 units.
The documented reason for this recall is: Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm. Distribution data in the federal record shows the product reached: US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX.. 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
82 units
Related Recalls
6
3 from same agency
Product description
Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjustment to fusion in the treatment of degenerative disc disease (DDD), sponylolisthesis, spinal stenosis, tumors, trauma (i.e. fracture).
Reason for recall
Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0239-2018 |
| Date reported | December 20, 2017 |
| Date initiated | November 13, 2017 |
| Recalling firm | Amendia, Inc dba Spinal Elements |
| Firm location | Marietta, GA |
| Affected scope | 82 units |
| Distribution | US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX. |
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-0239-2018) 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? ▼
Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjustment to fusion in the treatment of degenerative disc disease (DDD), sponylolisthesis, spinal stenosis, tumors, trauma (i.e. fracture).. Recalled by Amendia, Inc dba Spinal Elements. Units affected: 82 units.
Why was this product recalled? ▼
Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 20, 2017. Severity: Moderate. Recall number: Z-0239-2018.
Where was the recalled product distributed? ▼
Distribution: US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0239-2018) 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 December 20, 2017. 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.