The Recall Desk

Manufacturer

Amendia, Inc

11 recalls in our database name Amendia, Inc as the manufacturing or recalling firm.

What the numbers show

Total
11
Critical
0
Severe
1
Most recent
2018-01-17

Of the 11 recalls from Amendia, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (9%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–11 of 11

  • HighFDA (Devices)·Z-0316-2018·2018-01-10

    Amendia Recalls Ceres Self-Drilling Variable Screws Due to Incorrect Length Marking

    Amendia, Inc. is recalling 40 Ceres Self-Drilling Variable Screws because some units marked as 12 mm actually measure 14 mm in length.

    Product
    Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1885-2017·2017-05-03

    Amendia Recalls Mislabeled Nitinol Guide Wires for Spinal Surgery

    Amendia is recalling 15 units of K-Wires labeled as stainless steel but made of nitinol. The wires were distributed to Georgia, Kansas, and Texas.

    Product
    01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are used to establish a pathway into the bony pedicle to place implants during spinal s
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0966-2017·2017-01-18

    Amendia Recalls Ceres-C Cervical Interbody Devices Due to Missing Pin

    Amendia, Inc. is recalling six Ceres-C Standalone Cervical Interbody devices because they are missing a tantalum market pin.

    Product
    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.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0887-2017·2016-12-28

    Amendia Recalls Black Widow Spinal Screws Due to Mating Feature Defect

    Amendia, Inc. is recalling 96 units of Black Widow 6.6mm spinal screws due to a design defect in the mating feature between the plate and screw.

    Product
    Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, Part Number TBS030 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0891-2017·2016-12-28

    Amendia Recalls Optimus Fixed Awl Due to Tip Breakage During Surgery

    Amendia, Inc. is recalling nine Optimus Fixed Awl devices because the tip broke after impaction during surgery. The devices were distributed to Florida, Georgia, Illinois, Missouri, and Texas.

    Product
    Optimus Fixed Awl
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0886-2017·2016-12-28

    Amendia Recalls Black Widow Spinal Plates Due to Mating Feature Defect

    Amendia, Inc. is recalling 48 units of Black Widow Buttress Plates due to a design defect in the mating feature between the plate and screw.

    Product
    Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0883-2017·2016-12-28

    Amendia Savannah-T Straight Rods Recalled for Packaging Seal Defects

    Amendia, Inc. is recalling Savannah-T Straight Rods because some packages have unacceptable seals with compromised integrity.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0882-2017·2016-12-28

    Amendia Dual Stylet Needle Recall Due to Unacceptable Packaging Seals

    Amendia, Inc. is recalling 1,078 Dual Stylet Needles because packaging seals are compromised by channels or voids, potentially affecting product integrity.

    Product
    Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0881-2017·2016-12-28

    Amendia Recalls K-Wires Due to Unacceptable Packaging Seals

    Amendia, Inc. is recalling 5,833 units of K-Wires because the packaging seals are unacceptable, with some showing compromised integrity due to channels or voids.

    Product
    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 inc
    Category
    Medical Device
    Distribution
    Distributed nationwide