CLASS II Device recall · Reported 10 Jan 2018 · FDA Enforcement Report
Ceres Self-Drilling Variable Screw 0 The Ceres screws are recalled
Amendia is recalling Ceres Self-Drilling Variable Screw 0 The Ceres screws are self-drilling variable screws, distributed in Alabama, Florida, Georgia, New York, Texas, Virginia. The recall was initiated on 7 Jul 2017 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-0316-2018
- FDA event ID
- 77986
- Recalling firm
- Amendia, Marietta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jul 2017
- FDA classified
- 4 Jan 2018
- Reported
- 10 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Jul 2017 | Recall initiated by company | |
| 4 Jan 2018 | Classified by FDA | +181 days |
| 10 Jan 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for 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.
Product as listed by the FDA
Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System.
Where it was distributed
Distributed to states of: AL, FL, GA, NY, TX, and VA.
Questions about this recall
Is Ceres Self-Drilling Variable Screw 0 The Ceres screws are self-drilling variable screws recalled?
Yes. Amendia recalled Ceres Self-Drilling Variable Screw 0 The Ceres screws are self-drilling variable screws on 7 Jul 2017. The recall is Class II and its status is Terminated. Recall number Z-0316-2018.
Why was it recalled?
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.
Which lots are affected?
Model # 12-31-4012, Lot #133039
Where was it sold?
Distributed to states of: AL, FL, GA, NY, TX, and VA.
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.
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