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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
See all 2 products in this recall →Related recalls
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