DePuy Concorde Lift Torque Limiting Handle Recalled for Breakage Risk
DePuy Orthopaedics is recalling 130 Concorde Lift Torque Limiting Handles due to a potential for intra-operative breakage of driver tips.
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. The hazard involves a risk of harm (intra-operative breakage) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 130 units of the Concorde Lift Torque Limiting Handle. This medical device is intended to be used with supplemental internal spinal fixation systems cleared for use in the lumbar spine. The recall is being conducted because of a potential for intra-operative breakage of the driver tips.
The affected units were distributed nationwide. The specific product code is 287804102, and the affected lot numbers are 122315-B R, 122315-A R, and 041117A.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected handles. They should contact DePuy Orthopaedics for instructions on how to return the devices.
The recalled product
- Product
- Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
- Manufacturer
- DePuy Orthopaedics, Inc.
- Hazard
- Affected units
- 130
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 (3)
- Product code: 287804102 Lot number: 122315-B R
- 122315-A R
- 041117A
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by DePuy Orthopaedics, 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 2 products in this recall →Related recalls
Same manufacturer · DePuy Orthopaedics, Inc.
See all →- HighATTUNE AFFIXIUM Knee Implant Component Recalled for Incorrect Labeling
FDA (Devices) · 2024-04-10
- HighAttune Revision Limb Preservation System Tibial Insert Recalled for Over-Irradiation
FDA (Devices) · 2023-03-29
- HighDePuy Attune Tibial Insert Recalled for Excessive Radiation Exposure
FDA (Devices) · 2023-03-29
- HighOrthopedic Implant Recall: Excessive Radiation Exposure in Revision Tibial Insert
FDA (Devices) · 2023-03-29
- HighOrthopedic Tibial Insert Recalled Due to Excessive Radiation Exposure
FDA (Devices) · 2023-03-29
Same hazard · breakage
See all →- ModeratePapablic Replacement Brush Heads Recalled for Potential Breakage
FDA (Devices) · 2026-07-22
- ModeratePapablic Replacement Brush Heads Recalled Due to Breakage Risk
FDA (Devices) · 2026-07-22
- SevereMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- HighMedline Convenience Kits Containing Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08