Amendia Recalls Ceres-C Cervical Interbody Devices Due to Missing Pin
Amendia, Inc. is recalling six Ceres-C Standalone Cervical Interbody devices because they are missing a tantalum market pin.
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 medical device with a structural defect (missing pin) where no injuries or illnesses have been reported, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Amendia, Inc. is recalling six Ceres-C Standalone Cervical Interbody devices. The recall is due to the absence of a tantalum market pin in the devices.
The Ceres-C Standalone Cervical Interbody is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at the one level from C2-T1. The affected units are identified by specific part and lot numbers: Part Number 08-170-1010 (Lot 134926), Part Number 08-170-1011 (Lot 134927), Part Number 08-170-1006 (Lot 134929), and Part Number 08-170-1008 (Lot 134931).
The devices were distributed in the United States to Georgia only. The source text does not specify the number of patients affected or report any injuries or illnesses associated with the missing pin.
The recalled product
- Product
- Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at the one level from C2-T1.
- Manufacturer
- Amendia, Inc
- Hazard
- Affected units
- 6
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 (4)
- Part Number 08-170-1010 - Lot Number 134926
- Part Number 08-170-1011 - Lot Number 134927
- Part Number 08-170-1006 - Lot Number 134929
- Part Number 08-170-1008 - Lot Number 134931
Distribution
Distributed in 1 state:
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