Z-2355-2020 Class II Ongoing
FDA device recall Z-2355-2020 was initiated by Acuity Surgical Devices, LLC on January 7, 2019 and is designated Class II. Reason for recall: Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage. The recall status is ongoing. Affected quantity: A total of 27 lots producing 178 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2020
- Initiation Date
- January 7, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- A total of 27 lots producing 178 units
Product 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.
Reason for Recall
Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
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
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