Home / Recalls / Amendia, Inc / Z-0966-2017

Z-0966-2017 Class II Terminated

Recalled by Amendia, Inc — Marietta, GA

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

Other recalls by Amendia, Inc

  • Z-0325-2018 Class II — Mac Pin Non-Cannulated Screw, 6.5 x 60mm (July 7, 2017)
  • Z-0316-2018 Class II — Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drill (July 7, 2017)
  • Z-1885-2017 Class II — 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, M (April 6, 2017)
  • Z-0886-2017 Class II — Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, (November 22, 2016)
  • Z-0883-2017 Class II — Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, (November 22, 2016)
  • Z-0887-2017 Class II — Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Scr (November 22, 2016)
  • Z-0891-2017 Class II — Optimus Fixed Awl (November 22, 2016)
  • Z-0881-2017 Class II — K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x (November 22, 2016)
  • Z-0882-2017 Class II — Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the (November 22, 2016)
  • Z-0827-2017 Class II — Zeus-P Lumbar Interbody Device (November 22, 2016)