DePuy Spine Recalls Concorde Lift Spinal Fusion Implants
DePuy Spine is recalling Concorde Lift spinal fusion implants due to a complaint trend of post-operative loss of height and migration.
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 (loss of height and migration) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
DePuy Spine, Inc. is recalling the Concorde Lift, Expandable Interbody Device, a spinal fusion implant. The recall involves specific convex sizes including 9x21, 9x26, 11x21, and 11x26, with a total of 3,166 units affected. The devices were distributed nationwide in the United States and in 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. This issue affects patients who have received these specific spinal fusion devices.
Patients who have had these implants should contact their healthcare provider for further evaluation and guidance. The recall covers all lots of the affected product sizes.
The recalled product
- Product
- Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
- Manufacturer
- DePuy Spine, Inc.
- Category
- Medical Device — Spinal Implant
- Hazard
- 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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