TriMed Inc. Recalls Hex Drivers Due to Epoxy Color Band Migration
TriMed Inc. is recalling 1,525 hex drivers because the epoxy color band may migrate down the shaft or onto sterilization trays after sterilization.
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 risk of harm (material migration) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
TriMed Inc. is recalling 1,525 hex drivers, including part numbers HXDRIVER-2.0 AO, HXDRIVR-2.5 AO, HXDRIVR-2.5CL AO, DVHX-2.5/130C AO, HXDRIVR-3.0 AO, and HXDRIVER-3.5AO. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall is issued because, following the completion of sterilization cycles, the epoxy color band on the affected hex drivers can migrate down the shaft and potentially onto the sterilization tray or caddy. This migration may occur during the sterilization process.
The affected devices were distributed in the US, China, and Latin America. The specific lot numbers involved are 922361, 922362, 91956, 91957, 92237, 92238, 91858, 92235, 92656, 91856, and 91857. Users should check their inventory for these part numbers and lot numbers to determine if they are affected.
The recalled product
- Product
- Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; Hex Driver Part Number HXDRIVER-3.5AO
- Manufacturer
- TriMed Inc.
- Affected units
- 1,525
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 (11)
- Affected lot numbers: 922361
- 922362
- 91956
- 91957
- 92237
- 92238
- 91858
- 92235
- 92656
- 91856
- 91857
Distribution
Distribution scope not specified by the agency.
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