Recall Z-2355-2020
Acuity Surgical Devices, LLC · initiated January 7, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
Reason for recall
Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
FDA-determined cause: Process control
Action taken
On 12/14/2018, the firm notified its supplier via email requesting to visually review its inventory which determined that some screw holes were oval shaped. On 7/23/2019, all inventory was quarantined as part of the removal and was scrapped from inventory. Due to the low risk to patients and low probability, the firm ownly initially begin removal of product from internal locations (main warehouse) for the purpose of inspection and if necessary, repair or destruction. Removal Summary No additional customer or distributor communication took place during the removal.
Details
- Recall number
- Z-2355-2020
- Initiated
- January 7, 2019
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Quantity
- A total of 27 lots producing 178 units
- Distribution
- US Nationwide distribution including in the states of TX, FL, NC, LA, KY, WI, SD, IL, CA, and KS. O.U.S.: None
- Recalling firm
- Acuity Surgical Devices, LLC, Irving, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2354-2020 Class II | A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary…Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the… | 01/07/2019Open, Classified |