Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
Reported: May 8, 2019 Initiated: April 8, 2019 #Z-1225-2019
Product Description
Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
Reason for Recall
A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
Details
- Recalling Firm
- DePuy Spine, Inc.
- Units Affected
- 3166 total
- Distribution
- US Nationwide distribution. Foreign distribution to Austria, Switzerland, and United Kingdom.
- Location
- Raynham, MA
Frequently Asked Questions
What product was recalled? ▼
Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C). Recalled by DePuy Spine, Inc.. Units affected: 3166 total.
Why was this product recalled? ▼
A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 8, 2019. Severity: Moderate. Recall number: Z-1225-2019.
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