FDA Enforcement
Class II
Terminated
Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-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.
Recall: Z-1697-2021
·
Reported June 9, 2021
Enforcement
- Recall Number
- Z-1697-2021
- Event ID
- 87905
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- K2M, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- June 9, 2021
- Initiation Date
- May 7, 2021
- Classification Date
- June 1, 2021
- Termination Date
- March 8, 2023
- Address
- 600 Hope Pkwy SE, Leesburg, VA, 20175-4428, United States
Description
Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-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
Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
Code Info
Lot Number: NCNE-4437924 Expiration Date 12-10-2025
Distribution
Worldwide distribution - US Nationwide distribution in the states of MA, MI, NJ, PA, UT and the countries of Italy, Netherlands.
Quantity
3 units