Z-1226-2019 Class II Terminated
FDA device recall Z-1226-2019 was initiated by DePuy Spine, Inc. on April 8, 2019 and is designated Class II. Reason for recall: A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants. The recall status is terminated (terminated January 12, 2023). Affected quantity: 3166 total.
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2019
- Initiation Date
- April 8, 2019
- Termination Date
- January 12, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3166 total
Product Description
Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L)
Reason for Recall
A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
Distribution Pattern
US Nationwide distribution. Foreign distribution to Austria, Switzerland, and United Kingdom.
Code Information
All lots