CLASS II ONGOING Device recall · Reported 22 May 2024 · FDA Enforcement Report
Threaded IM Nail, TI recalled by TriMed
TriMed is recalling TriMed, Threaded IM Nail, TI, distributed nationwide in the US. The recall was initiated on 19 Mar 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1791-2024
- FDA event ID
- 94381
- Recalling firm
- TriMed, Santa Clarita, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Mar 2024
- FDA classified
- 10 May 2024
- Reported
- 22 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 19 Mar 2024 | Recall initiated by company | |
| 10 May 2024 | Classified by FDA | +52 days |
| 22 May 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide AlaskaArkansasArizonaCaliforniaFloridaHawaiiIllinoisLouisianaMassachusettsMichiganNorth CarolinaNew JerseyNevadaOhioOklahomaPennsylvaniaTennesseeTexasUtahVirginia
Questions about this recall
Is Threaded IM Nail, TI recalled?
Yes. TriMed recalled Threaded IM Nail, TI on 19 Mar 2024. The recall is Class II and its status is Ongoing. Recall number Z-1791-2024.
Why was it recalled?
Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
Which lots are affected?
UDI: 00842188127878/ Lot # QM23086
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from TriMed
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Threaded IM Nail, TI recalled by TriMed | TriMed | Sterility | Nationwide |
| Device | CLASS II | Volar Bearing Plate recalled by TriMed | TriMed | Other | 5 states |
| Device | CLASS II | RipCord Syndesmosis Button recalled by TriMed | TriMed | Device Malfunction | Nationwide |
| Device | CLASS II | Wrist Hook Dorsal Impactor recalled by TriMed | TriMed | Sterility | Nationwide |
| Device | CLASS II | Olecranon Hook Plate, Lt, 6-Holes recalled by TriMed | TriMed | Sterility | Nationwide |
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