TriMed Locking Drill Guide Recall Due to Epoxy Coating Defect
TriMed Inc. is recalling 1,042 Locking Drill Guides because the epoxy coating on the instruments can pop off.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a physical defect (epoxy popping off) on a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
TriMed Inc. is recalling 1,042 units of the TriMed Locking Drill Guide, 2.3mm (REF GUIDELCBS-2.3). The recall involves nonsterile, prescription-only medical devices manufactured by TriMed Inc. in Santa Clarita, California.
The recall is being issued because the epoxy on the Apex-manufactured epoxy-coated instruments can pop off. This defect could potentially affect the integrity of the instrument during use.
The affected products were distributed nationwide, as well as to military facilities and foreign locations in Australia, China, South Africa, and Sweden. The specific lot numbers involved are 3168, 3464, 3660, 3963, and 4216. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
- Manufacturer
- TriMed Inc.
- Hazard
- Affected units
- 1,042
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot numbers 3168
- 3464
- 3660
- 3963
- and 4216.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by TriMed Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · TriMed Inc.
See all →- HighTriMed Threaded IM Nail System Recalled for Driver-Socket Defect
FDA (Devices) · 2024-05-22
- HighTriMed Threaded IM Nails Recalled Due to Out-of-Spec Driver-Socket Defect
FDA (Devices) · 2024-05-22
- HighVolar Bearing Plate wrist fixation systems recalled for bearing dislodgement
FDA (Devices) · 2024-02-07
- HighRipCord Syndesmosis Button suture may break during orthopedic surgery
FDA (Devices) · 2023-02-15
- ModerateTriMed Peg Guide Extender Recalled Due to Rusting Spring Hazard
FDA (Devices) · 2019-11-20
Same hazard · material defect
See all →- LowParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- ModerateParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- HighNexxZr dental zirconia discs may have reduced or missing dentin layer
FDA (Devices) · 2026-06-17
- HighMAC two-lumen central venous kits recalled over incorrectly manufactured adhesive
FDA (Devices) · 2026-04-29
- HighArrowg+ard Blue Plus four-lumen CVC kits recalled over adhesive manufacturing
FDA (Devices) · 2026-04-29