Amendia Recalls
11 recalls on record · December 28, 2016 to January 17, 2018 · Medical Devices
Recalls by year
16
17
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
January 17, 2018Medical DevicesFDA
Amendia, Inc recalls Mac Pin Non-Cannulated Screw, 6.5 x 60mm
Hazard: Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.
January 10, 2018Medical DevicesFDA
Amendia, Inc recalls Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to
Hazard: Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws. Although the laser mark and color identify the screws as 12 mm in length, some screws in the lot measure 14 mm in length.
May 3, 2017Medical DevicesFDA
Amendia, Inc recalls 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM
Hazard: Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.
January 18, 2017Medical DevicesFDA
Amendia, Inc recalls Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicate
Hazard: Absent tantalum market pin.
December 28, 2016Medical DevicesFDA
Amendia, Inc recalls Optimus Fixed Awl
Hazard: Complaints that the tip of the awl broke after impaction during surgery.
December 28, 2016Medical DevicesFDA
Amendia, Inc recalls Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6m
Hazard: There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw.
December 28, 2016Medical DevicesFDA
Amendia, Inc recalls Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 The Black Widow But
Hazard: There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw.
December 28, 2016Medical DevicesFDA
Amendia, Inc recalls Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T
Hazard: The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
December 28, 2016Medical DevicesFDA
Amendia, Inc recalls Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Ne
Hazard: The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
December 28, 2016Medical DevicesFDA
Amendia, Inc recalls 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-Thr
Hazard: The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
December 28, 2016Medical DevicesFDA
Amendia, Inc recalls Zeus-P Lumbar Interbody Device
Hazard: Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated that the primary label and patient label did not match. The primary label matched the label on the inner pouch, but the patient label was incorrect.