Device product
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.
Z-2355-2020
Product summary
- Event
- Event 85642
- Status
- Ongoing
- Classification
- Class II
- Quantity
- A total of 27 lots producing 178 units
- Official record key
device-enforcement:Z-2355-2020
Official wording
Reason: Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
Code information: 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
Distribution pattern: US Nationwide distribution including in the states of TX, FL, NC, LA, KY, WI, SD, IL, CA, and KS. O.U.S.: None
Derived failure modes
-
Unknown
Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.