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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
Related recalls
Same manufacturer · Amendia, Inc
See all →- ModerateAmendia Recalls Mac Pin Non-Cannulated Screws Due to Incorrect Length Labeling
FDA (Devices) · 2018-01-17
- ModerateAmendia Recalls Mislabeled Nitinol Guide Wires for Spinal Surgery
FDA (Devices) · 2017-05-03
- HighAmendia Recalls Ceres-C Cervical Interbody Devices Due to Missing Pin
FDA (Devices) · 2017-01-18
- HighAmendia Recalls Black Widow Spinal Plates Due to Mating Feature Defect
FDA (Devices) · 2016-12-28
- ModerateAmendia Savannah-T Straight Rods Recalled for Packaging Seal Defects
FDA (Devices) · 2016-12-28
Same hazard · mis labeling
See all →- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
Similar recalls
- ModerateAmendia Recalls Mac Pin Non-Cannulated Screws Due to Incorrect Length Labeling
FDA (Devices) · 2018-01-17
- ModerateZimmer Biomet Recalls Mobi-C Distraction Screws Due to Labeling Error
FDA (Devices) · 2019-06-26
- HighFDA Recalls Piranha Cervical Spine Screws Due to Incorrect Length Marking
FDA (Devices) · 2017-12-20
- ModerateAlphatec Spine Recalls Mislabeled 14mm Trestle Luxe Cervical Screws
FDA (Devices) · 2015-05-06
- ModerateInnovasis Recalls Opteryx Variable Rescue Screws with Incorrect Size Engraving
FDA (Devices) · 2017-05-31
- ModerateOrthoPediatrics Recalls 7.0mm Pedicle Screws Due to Color Anodizing Error
FDA (Devices) · 2018-02-21