Amendia Recalls Ceres Self-Drilling Variable Screws Due to Incorrect Length Marking
Amendia, Inc. is recalling 40 Ceres Self-Drilling Variable Screws because some units marked as 12 mm actually measure 14 mm in length.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the incorrect length could lead to improper surgical placement, but the source text does not report any injuries or illnesses.
Plain-English summary
Amendia, Inc. is recalling 40 units of the Ceres Self-Drilling Variable Screw 4.0 x 12mm (Model # 12-31-4012, Lot #133039). These medical devices are intended to be used with the Ceres-C Stand-Alone Cervical System.
The recall was initiated due to incorrect direct marking and color identification. Although the laser mark and color code identify the screws as 12 mm in length, some screws in the affected lot measure 14 mm in length.
The affected products were distributed to the states of Alabama, Florida, Georgia, New York, Texas, and Virginia. The source text does not specify instructions for consumers or healthcare providers regarding the disposition of these devices.
The recalled product
- Product
- 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.
- Manufacturer
- Amendia, Inc
- Affected units
- 40
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model # 12-31-4012
- Lot #133039
Distribution
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