Z-0966-2017 Class II Terminated
FDA device recall Z-0966-2017 was initiated by Amendia, Inc on November 22, 2016 and is designated Class II. Reason for recall: Absent tantalum market pin. The recall status is terminated (terminated February 28, 2017). Affected quantity: 6 devices.
Recall Details
- Product Type
- Devices
- Report Date
- January 18, 2017
- Initiation Date
- November 22, 2016
- Termination Date
- February 28, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 devices
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.
Reason for Recall
Absent tantalum market pin.
Distribution Pattern
US Distribution to GA only.
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