Z-0092-2019Class II

AVS Aria Cage, Catalog Number 48753212

Name: Z-0092-2019 AVS Aria Cage, Catalog Number 48753212
Creator: Stryker Spine
Published: 2018-08-13
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2018-08-13 / Terminated / root cause: labeling and UDI

FDA source

Stryker Spine began a recall of 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... on 2018-08-13. FDA classified it as Class II and gives the reason as "The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0092-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-13
Posted: 2018-10-10
Terminated: 2019-05-23
Recalling firm: Howmedica Osteonics Corp
Product: 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 use in the lumbosacral spine.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage.
Root cause tag: labeling and UDI
FDA 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 retrieving product located at a Health Care Facility I Hospital or end user, the sales representative must do the following: Deliver the Health Care Facility Recall Notification letter to the Health Care Facility I Hospital Representative that the sales representative is retrieving the product from. Have the Health Care Facility I Hospital Representative fill out and sign the Product Recall Acknowledgement Form (attached to Health Care Facility Notification letter). Return the affected products retrieved and the completed Product Recall Acknowledgement Form to the branch/agency personnel responsible for executing the recall. 3. Use Customer Response Form to reconcile any affected product listed above. Complete Customer Response Form even if there is no effected product identified. 4. Within 5 days of receipt of this notice, the branch/agency personnel responsible for executing the recall must send completed and signed the Customer Response Form and the Product Acknowledgement Forms (from the Health Care Facilities) if applicable to Stryker Spine via: email: [email protected] All forms must filled out completely and all information must be reconciled accurately 5. Within 5 days of receipt of this notice, mail any affected product via FedEx Acct # 346869500 to: Attn: Christa Joisil - Regulatory Compliance Stryker Spine, 59 Route 17S All
Quantity in commerce: 5
Distribution: US Nationwide in the states: CA, FL, GA, MI, MN, NJ, NM, and OR
Product codes and lots: Lot Number 7HX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0092-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0092-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-17	2018-10-09

Product code MAX

K151726Class IIAVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK SpacerStryker Corporation / cleared 2016-01-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)