Amendia, Inc: Medical Device Recall in 2016 - (Recall #: Z-0881-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: November 22, 2016

Date Posted: December 28, 2016

Recall Number: Z-0881-2017

Event ID: 75858

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.

Status: Terminated

Product Quantity: 5833 units

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.

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

Voluntary or Mandated:

Voluntary: Firm initiated