Device recall: 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

FDA enforcement event 94381 · Class II · initiated 19 Mar 2024 · status Ongoing

DeviceVoluntary: Firm initiated2 product recordsSanta Clarita, CA

TriMed Inc. (Santa Clarita, CA) initiated this device recall on 19 Mar 2024; FDA lists 2 product records under event 94381, 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. 87% of the 970 device enforcement events initiated in 2024 carry the same class.

Status: Ongoing. 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

"Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque."

Distribution

"US Nationwide distribution in the states of AK, AR, AZ, CA, FL, HI, IL, LA, MA, MI, NC, NJ, NV, OH, OK, PA, TN, TX, UT, VA, WA, WI."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1791-2024	TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only	142 units	Class II	Ongoing	22 May 2024
Z-1792-2024	TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only	120 units	Class II	Ongoing	22 May 2024

Context

87%of 2024 device events are Class II970 events that year

2product records 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
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
24 Aug 2018	TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. T	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: "Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque."

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 Nationwide distribution in the states of AK, AR, AZ, CA, FL, HI, IL, LA, MA, MI, NC, NJ, NV, OH, OK, PA, TN, TX, UT, VA, WA, WI."

Is the recall still ongoing?

FDA lists the status as Ongoing. "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.