FDA
A LINK Z INTERVERTEBRAL BODY FUSION DEVICE
Product Description:
A Link Z Ti Unitary Plate-Cage 32x21x15 7
A Link Z Ti Unitary Plate-Cage 32x21x15 12
A Link Z Ti Unitary Plate-Cage 32x21x15 16
A Link Z Ti Unitary Plate-Cage 32x21x15 16
A Link Z Ti Unitary Plate-Cage 32x21x15 16
A Link Z Ti Unitary Plate-Cage 32x21x15 20
A Link Z Ti Unitary Plate-Cage 32x21x15 20
A Link Z Ti Unitary Plate-Cage 32x21x15 20
A Link Z Ti Unitary Plate-Cage 32x21x17 12
A Link Z Ti Unitary Plate-Cage 32x21x17 16
A Link
Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
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.