DePuy Concorde Lift Driver Shaft Recalled for Potential Breakage
DePuy Orthopaedics is recalling 130 units of the Concorde Lift Driver Shaft AO 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 and involves a risk-of-harm product (intra-operative breakage) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 130 units of the Concorde Lift Driver Shaft AO. This medical device is used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine. The recall is being conducted due to a potential for intra-operative breakage of the driver tips.
The affected product is identified by product code 287804101G and lot numbers 052316-A R and 121416-A R. The units were distributed nationwide. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and facilities should stop using the affected devices and contact DePuy Orthopaedics for instructions on how to return or dispose of the product.
The recalled product
- Product
- Concorde Lift Driver Shaft AO. 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 (2)
- Product code: 287804101G Lot number: 052316-A R
- 121416-A R
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.
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