Amendia, Inc.
United StatesFDA applicant, unverified
- Devices
- 16
- FDA recalls
- 11
At a glance
Market reach
- United States
- FDA recalls
What Amendia, Inc. makes
Amendia, Inc. manufactures spinal fixation and fusion devices, including interbody fusion systems for lumbar and cervical spine applications, cervical plates, and pedicle screw systems. Their portfolio also includes stabilization systems for the cervical spine, facet-based stabilization implants, and anterior cervical plating solutions designed for surgical spinal stabilization.
The company’s devices are classified as Class II or Unclassified under FDA regulations and are authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Search and filter all 16 devicesFDA recalls
FDA recall records list 11 recalls initiated by Amendia, Inc., the earliest on 2016-11-22 and the most recent on 2017-07-07. By recorded status: 11 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 3
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 7 Jul 2017 Z-0316-2018 Class II Terminated 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.
- 7 Jul 2017 Z-0325-2018 Class II Terminated 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.
- 6 Apr 2017 Z-1885-2017 Class II Terminated Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.
2016
- 22 Nov 2016 Z-0827-2017 Class II Terminated 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.
- 22 Nov 2016 Z-0881-2017 Class II Terminated The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
Full distribution text
- 22 Nov 2016 Z-0882-2017 Class II Terminated The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
Full distribution text
- 22 Nov 2016 Z-0883-2017 Class II Terminated The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
Full distribution text
- 22 Nov 2016 Z-0886-2017 Class II Terminated 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.
- 22 Nov 2016 Z-0887-2017 Class II Terminated 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.
- 22 Nov 2016 Z-0891-2017 Class II Terminated Complaints that the tip of the awl broke after impaction during surgery.
Show all 11 recalls
2016
- 22 Nov 2016 Z-0966-2017 Class II Terminated Absent tantalum market pin.
Frequently asked questions
How many devices does Amendia, Inc. have in the registry?
The registry currently lists 16 devices for Amendia, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Amendia, Inc.'s devices?
Among its 16 most recently registered devices, Amendia, Inc. has devices listed in FDA 510(k) (16 devices).
What risk classes do Amendia, Inc.'s devices fall under?
Among its 16 most recently registered devices, the classes recorded for Amendia, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Amendia, Inc.?
FDA recall records list 11 recalls initiated by Amendia, Inc., the most recent initiated on 7 Jul 2017. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Amendia, Inc. in the registry?
The most recently registered devices listed for Amendia, Inc. include Amendia Interbody Fusion Devices, Amendia Stand-Alone Cervical System, Syzygy Stabilization System and SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK.