Z-1695-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 9, 2021
- Initiation Date
- May 7, 2021
- Termination Date
- March 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct to fusion in patients with degenerative disc disease.
Reason for Recall
Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of MA, MI, NJ, PA, UT and the countries of Italy, Netherlands.
Code Information
Lot Number: NCMR-4437922 Expiration Date 12-10-2025