Recall Z-1225-2019
DePuy Spine, Inc. · initiated April 8, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
Codes / lots: All lots
Reason for recall
A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
FDA-determined cause: Under Investigation by firm
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).
Details
- Recall number
- Z-1225-2019
- Initiated
- April 8, 2019
- Posted by FDA
- April 27, 2019
- Terminated
- January 12, 2023
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Quantity
- 3166 total
- Distribution
- US Nationwide distribution. Foreign distribution to Austria, Switzerland, and United Kingdom.
- Recalling firm
- DePuy Spine, Inc., Raynham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1226-2019 Class II | Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23…A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants. | 04/08/2019Terminated |