A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Interbody 32x24x12 12 A Link Z Ti Unitary Open Interbody 32x24x16 7 A Link Z Ti Unitary Open Interbody 32x24x16 12 Product Usage: is a spinal device that is implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion.
Enforcement
- Recall Number
- Z-2355-2020
- Event ID
- 85642
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Acuity Surgical Devices, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Other
- Report Date
- June 17, 2020
- Initiation Date
- January 7, 2019
- Classification Date
- June 11, 2020
- Address
- 8710 N Royal Ln, N/A, Irving, TX, 75063-2539, United States
Description
A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Interbody 32x24x12 12 A Link Z Ti Unitary Open Interbody 32x24x16 7 A Link Z Ti Unitary Open Interbody 32x24x16 12 Product Usage: is a spinal device that is implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion.
Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
Product Product Description Lot Number Number 15-32241207 A Link Z Ti Unitary Open Interbody 32x24x12 7 1000572 15-32241212 A Link Z Ti Unitary Open Interbody 32x24x12 12 1000573 15-32241607 A Link Z Ti Unitary Open Interbody 32x24x16 7 1000576 15-32241612 A Link Z Ti Unitary Open Interbody 32x24x16 12 1000577
US Nationwide distribution including in the states of TX, FL, NC, LA, KY, WI, SD, IL, CA, and KS. O.U.S.: None
A total of 27 lots producing 178 units