Device recall: TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. T

FDA enforcement event 82209 · Class II · initiated 24 Aug 2018 · status Terminated · terminated 28 Dec 2020

DeviceVoluntary: Firm initiated1 product recordSanta Clarita, CA

TriMed Inc. (Santa Clarita, CA) initiated this device recall on 24 Aug 2018; FDA lists 1 product record under event 82209, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 28 Dec 2020. Initiation: voluntary: firm initiated. TriMed Inc. has 11 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

TriMed Inc., Santa Clarita, CA.

Reason for recall

"The bone screw is shorter than the intended design specification."

Distribution

"US Distribution to states of FL and MO."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1214-2019	TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The HEX4.0-40 Screw is a single piece machined cortical bone screw. The HEX4.0-40 screw is employed in combination with a…	13 screws	Class II	Terminated	1 May 2019

Context

92%of 2018 device events are Class II1,074 events that year

1product record in this eventfirm median: 1

11events on this register for the firm

Other enforcement events for TriMed Inc.

Initiated	Product (first record)	Type	Class	Records
19 Mar 2024	TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65m	Device	Class II	2
28 Nov 2023	Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N	Device	Class II	1
22 Dec 2022	RipCord Syndesmosis Button, REF: STA001K	Device	Class II	1
28 Sep 2018	TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita,	Device	Class II	5
24 Aug 2018	TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varyi	Device	Class II	1
15 Aug 2018	TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The	Device	Class II	1
16 Apr 2018	Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the requir	Device	Class II	1
13 Apr 2018	Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19	Device	Class II	4
11 Jan 2018	Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO;	Device	Class II	1
29 Aug 2016	TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in le	Device	Class II	1

All 11 events for TriMed Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "The bone screw is shorter than the intended design specification."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Distribution to states of FL and MO."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 28 Dec 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.