Home / Recalls / Amendia, Inc / Z-0883-2017

Z-0883-2017 Class II Terminated

Recalled by Amendia, Inc — Marietta, GA

Recall Details

Product Type
Devices
Report Date
December 28, 2016
Initiation Date
November 22, 2016
Termination Date
February 1, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
240 units

Product Description

Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part Number 10704-400; Savannah-T Straight Rod, 500mm; Savannah-T High Top Straight Rod, 200mm; Savannah-T High Top Straight Rod, 220mm, Part Number 1705-220; Savannah-T High Top Straight Rod, 240mm, Product Code 10705-240; Savannah-T Straight Rod, 260mm, Part Number 10705-260; Savannah-T Straight Rod, 280mm, Part Number 10705-280; Savannah-T Straight Rod, 300mm, Part Number 10705-300; Savannah-T Notched Curved Rod, 200mm, Part Number 10706-200; Savannah-T Curve Rod, 200mm, Part Number 10707-200 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone

Reason for Recall

The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.

Distribution Pattern

Nationwide Distribution to AL, AZ, AR, CA, CO, FL, GA, IA, KS, KY, LA, MA, MI, MN, MO, NV, NJ, NC, SC, TN, TX, VA, WA, WV, WI and Puerto Rico

Code Information

Part Number 10704-200 Lot Number 124422, 129766, 130739, 132430; Part Number 10704-250 Lot Number 129790, 130738, 131211, 131309, 131310, 131509, 132811; Part Number 10704-300 Lot Number 129862, 134229; Part Number 10704-400 Lot Number 129861, 130145, 130147, 130502, 131499, 131646; Part Number 10704-500 Lot Number 127934, 127937, 129770, 129863, 130130, 130143, 130781, 134228; Part Number 10705-200 Lot Number 122654, 123583, 129773, 130131, 132153, 132154, 132762; Part Number 10705-220 Lot Number 128818, 131311, 132881; Part Number 10705-240 Lot Number 130500; Part Number 10705-260 Lot Number 121521, 131500, 132199; Part Number 10705-280 Lot Number 121519, 130740; Part Number 10705-300 Lot Number 130140, 130332, 134299; Part Number 10706-200 Lot Number 128522, 129567, 129781, 129891, 130741; Part Number 10707-200 Lot Number 128815, 129782, 129783, 129784, 130182, 131410, 132880.

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-0827-2017 Class II — Zeus-P Lumbar Interbody Device (November 22, 2016)
  • Z-0886-2017 Class II — Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, (November 22, 2016)
  • Z-0966-2017 Class II — Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior c (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-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-0882-2017 Class II — Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the (November 22, 2016)