Recall Z-0092-2019 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Stryker Spine
AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1 . The AVS ARIA TM PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for
| Date | Aug 13, 2018 |
| Status | Terminated |
| Reason | The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage. |
| Root cause | Error in labeling |
| Action | Product Recall notification letters dated 8/9/18 were distributed to Branch Managers instructing them to: Regional Sales Managers and Agency Principals are ultimately responsible for the following: 1. Examine your inventory and hospital I health care facility locations to identify any AVS ARIA cages with Catalog Number referenced above. 2. If there is any product located at a Health Care Facility I Hospital or end user, the branch/agency must coordinate with a sales representative or Branch/Agency personnel to retrieve the product from the Health Care Facility I Hospital or end user. When ret |
| Quantity | 5 |
| Distribution | US Nationwide in the states: CA, FL, GA, MI, MN, NJ, NM, and OR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151726 | AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, A Stryker Corporation, Jan 20, 2016 |