Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23
FDA device recall Z-1226-2019 · posted 2019-04-27 · Terminated
Recall details
- Recalling firm
- DePuy Spine, Inc.
- Reason for recall
- A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
- Action taken
- On 4/8/19, the firm distributed Medical Device Recall letters to its customers. The letter recommended that surgeons use alternative implants. In addition, customers were asked to immediately case use of the affected devices and to return all affected implants on hand. In addition, customers were asked to complete and return the business reply form. Customers were asked to notify surgeon users and others in the facility who need to be informed of the recall. If any affected product was forwarded to another facility, please immediately contact that facility to communicate the field action. For product-related questions, please contact your local DePuy Synthes Spine Sales Consultant. For questions about device recall information provided, please contact Stephanie Koenig, Recall Associate, at 574 371-4584 (M-F; 8 a.m. 5 p.m. EST).
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- MAX
- Quantity affected
- 3166 total
- Distribution
- US Nationwide distribution. Foreign distribution to Austria, Switzerland, and United Kingdom.
- Date initiated
- 2019-04-08
- Date posted
- 2019-04-27
- Date terminated
- 2023-01-12
- Location
- Raynham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Opticage(R) Expandable Interbody Fusion Device (K160464) | Interventional Spine, Inc. | 2016-04-04 |
| Opticage Expandable Interbody Fusion Device (K152156) | Interventional Spine, Inc. | 2015-10-19 |