DePuy Spine Recalls Concorde Lift Spinal Fusion Implants Due to Migration
DePuy Spine is recalling Concorde Lift spinal fusion implants because a complaint trend was observed for post-operative loss of height and migration.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (migration and loss of height) in a spinal implant, which meets the criteria for a Severe rating due to the potential for significant injury.
Plain-English summary
DePuy Spine, Inc. is recalling the Concorde Lift, Lordotic Expandable Interbody Device, a spinal fusion implant. The recall involves specific sizes including 9x23, 9x27, 11x23, and 11x27, with a total quantity of 3,166 units. The products were distributed nationwide in the United States and to Austria, Switzerland, and the United Kingdom.
The recall was initiated after a complaint trend was observed regarding post-operative loss of height and migration of the implants. The agency has classified this as a Class II recall.
Healthcare providers and patients should contact DePuy Spine, Inc. for further instructions regarding the removal or replacement of these devices.
The recalled product
- Product
- Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L)
- Manufacturer
- DePuy Spine, Inc.
- Affected units
- 3,166
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 (1)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by DePuy Spine, 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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