Amendia Ceres Self-Drilling Screws: Incorrect Length Marking Risk
Amendia recalls Ceres Self-Drilling Variable Screws 4.0 x 12mm due to incorrect length marking (some screws are 14mm instead of 12mm).
Lower-risk recall
Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws. Although the laser mark and color identify the screws as 12 mm in length, some screws in the lot measure 14 mm in length.
Contact the company
What happened, in plain English
Amendia recalls Ceres Self-Drilling Variable Screws 4.0 x 12mm because some screws in the affected lot are actually 14mm long instead of 12mm. This could cause improper installation in medical devices, potentially leading to complications. Read more at govinfonow.com/recall/73456-amendia-ceres-self-drilling-screws-incorrect-length-marking-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73456-amendia-ceres-self-drilling-screws-incorrect-length-marking-risk · Updated September 21, 2026 · FDA enforcement record: FDA #Z-0316-2018
Cite this page
“Amendia Ceres Self-Drilling Screws: Incorrect Length Marking Risk.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73456-amendia-ceres-self-drilling-screws-incorrect-length-marking-risk. Based on FDA recall #Z-0316-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0316-2018%22&limit=1).
Why it’s dangerous
The screws are marked as 12mm but some measure 14mm. This incorrect length could lead to improper installation in medical devices, potentially causing complications during surgery or device use.
Who’s affected
Users of the Ceres Self-Drilling Variable Screws 4.0 x 12mm (model #12-31-4012, lot #133039) for medical applications. Medical professionals and device installers are most at risk.
How to tell if you have this one
Check for model #12-31-4012 and lot #133039 on the Ceres Self-Drilling Variable Screws 4.0 x 12mm. The screws are intended for use with the Ceres-C Stand-Alone Cervical System.
- Brand
Amendia- Category
Medical device
What to do — step by step
Check Screw Length
Measure the screw to confirm it is 12mm long (some in the lot are 14mm).
Where it went and when
Where it was distributed
Distributed in 6 states.
FDA distribution: “Distributed to states of: AL, FL, GA, NY, TX, and VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Florida, Georgia, New York, Texas, Virginia.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0316-2018 (July 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0316-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.