Amendia, Inc: Medical Device Recall in 2017 - (Recall #: Z-0966-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 22, 2016

Date Posted: January 18, 2017

Recall Number: Z-0966-2017

Event ID: 75857

Reason for Recall:

Absent tantalum market pin.

Status: Terminated

Product Quantity: 6 devices

Code Information:

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 Pattern:

US Distribution to GA only.

Voluntary or Mandated:

Voluntary: Firm initiated