Home / Recalls / Amendia, Inc / Z-0881-2017

Z-0881-2017 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
5833 units

Product Description

K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080-18T; K-Wire Non-Threaded 1.4mm x 18, Part Number 9080-18U; 1.4mm x 24 Threaded Guide Wire, Part Number 9080-24T; K-Wire Non-Threaded 24, Part Number 9080-24U; Blunt K-Wire, 18 inches, Threaded, Part Number 9080B-18T; Blunt K-Wire, 18 inches, Unthreaded, Part Number 9080B-18U; Blunt K-Wire, 24 inches, Unthreaded, Part Number 9080B-24U; 1.4mm x 18 Blunt Threaded Nitinol Guide Wire, Part Number 9080B-N-18T; 1.4mm x 18" Blunt Non-Threaded Nitinol Guide Wire, Part Number 9080B-N-18U; Lodestar K-wire Non-Threaded, 18, Part Number 9080L-18U; 1.4mm x 18 Threaded Nitinol Guide Wire, Part Number 9080-N-18T; 1.4mm x 18 Non-Threaded Nitinol Guide Wire, Part Number 9080-N-18U 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 9080-12U Lot Number 121306, 121307, 122628, 122721, 124400, 132732, 135403; Part Number 9080-18T Lot Number 122486, 122626, 123957, 124408, 127435, 129132, 129803, 129935, 131072, 135560, 135566, 135567; Part Number 9080-18U Lot Number 122470, 123948, 129802, 129936, 130390, 130391, 131073; Part Number 9080-24T Lot Number 133359; Part Number 9080-24U Lot Number 134108, 134112, 134908; Part Number 9080B-18T Lot Number 124547, 126820, 127437, 131454, 132592, 134181, 135401; Part Number 9080B-18U Lot Number 122468, 123938, 126504, 127436, 129800, 130947, 131453, 132750, 133645, 134169, 134907, 135563, 135578, 135579, 135580; Part Number 9080B-24U Lot Number 122239, 130392, 130393, 131839, 133988, 135359, 135360, 135400; Part Number 9080B-N-18T Lot Number 124137, 125331, 128472, 130612, 132229, 135584, 135585, 137464; Part Number 9080B-N-18U Lot Number 123556, 125199, 126821, 128348, 128469, 129443, 129915, 130836, 131626, 133118, 134180, 135208; Part Number 9080L-18U Lot Number 127877, 128351, 130389, 130946, 133261, 135210, 135593; Part Number 9080-N-18T Lot Number 122488, 123863, 130914; Part Number 9080-N-18U Lot Number 122487, 123564, 124402, 126125, 129005, 129077, 133499, 135562, 137462.

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-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-0882-2017 Class II — Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the (November 22, 2016)