Recall Register

Food, drugs, devices › Firms

Amendia, Inc

FDA recalling firm · 8 enforcement events · 11 product records · 2016–2017 · GA

Amendia, Inc has 8 FDA enforcement events on this register (11 product records) between 2016 and 2017: 8 device; the busiest year was 2016 with 5.

0% of its events are Class I; the most common class is Class II (8). 0 events are listed as ongoing; the recalling firm's address is in GA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
7 Jul 2017Mac Pin Non-Cannulated Screw, 6.5 x 60mmDeviceClass II1Terminated
7 Jul 2017Ceres 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.DeviceClass II1Terminated
6 Apr 201701.4mm 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 surgeryDeviceClass II1Terminated
22 Nov 2016Optimus Fixed AwlDeviceClass II1Terminated
22 Nov 2016Zeus-P Lumbar Interbody DeviceDeviceClass II1Terminated
22 Nov 2016K-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;…DeviceClass II3Terminated
22 Nov 2016Black 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 regionDeviceClass II2Terminated
22 Nov 2016Ceres-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.DeviceClass II1Terminated

By type and class

Device8
Class II8

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

16
17
18
19
20
21
22
23
24
25
26
Enforcement events for Amendia, Inc by year initiated.

Questions and answers

How many FDA recalls has Amendia, Inc had?

8 enforcement events (11 product records) on this register, 2016–2017: 8 device.

Are any Amendia, Inc recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Amendia, Inc recalls?

8 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.