Recall Z-2354-2020 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Acuity Surgical Devices, LLC
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 32x2
| Date | Jan 7, 2019 |
| Status | Open, Classified |
| Reason | Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage. |
| Root cause | Process control |
| Action | 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. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133827 | A-LINK Z Osteo Vasive, LLC, Nov 17, 2014 |